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Guide

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref OGNR01LRef PGSPRRef PGSPMRef HGNR02LRef HGBESRef HGTMSRef OGUWSRef HGIF01SRef OGZB02LRef HGZB01LRef OGIF02SRef OGBELRef OGNR03LRef HGZB02LRef HGIF01LRef OGIF01LRef OGTRSRef HGAO02SRef OGAO02LRef OGIF02LRef HGUMSRef HGSTRLRef OGSRSRef HGNR03LRef HGNR04LRef OGNA01LRef HGNR03SRef HOGUMLRef OGNR02SRef OGTMLRef OGSTRLRef HGSB01LRef HOGSRLRef HGNA01LRef OGTRLRef HGZB02SRef OGUWLRef OGSB02SRef OGZB01SRef OGNR03SRef HGSB02SRef HGURSRef OGSB01SRef HOGURLRef HGNA01SRef OGNA02LRef OGSRLRef OGSTRSRef OGNA01SRef HGIF02SRef OGAO01SRef HGAO01SRef OGAO01LRef HGIF02L

by OSSTEM IMPLANT Co., Ltd.

Identity

Trade Name
Guide EUDAMEDFDA UDI
Guide Pin for Implant EUDAMEDFDA UDI
Generic Name
Surgical drill guide, reusable FDA UDI
Dental prosthesis/implant abutment screw analog, reusable FDA UDI
Device Name
Surgical Instrument System EUDAMED
Model / Reference
HGNR03L EUDAMEDFDA UDI
OGSRL EUDAMEDFDA UDI
OGBEL EUDAMEDFDA UDI
HGZB02S EUDAMEDFDA UDI
OGSB02S EUDAMEDFDA UDI
HOGURL EUDAMEDFDA UDI
HGSB02S EUDAMEDFDA UDI
OGAO01S EUDAMEDFDA UDI
OGNA01S EUDAMEDFDA UDI
HGNR04L EUDAMEDFDA UDI
HGAO01S EUDAMEDFDA UDI
OGNR03L EUDAMEDFDA UDI
PGSPR EUDAMEDFDA UDI
HGZB01L EUDAMEDFDA UDI
OGNR02S EUDAMEDFDA UDI
HGTMS EUDAMEDFDA UDI
HGNR02L EUDAMEDFDA UDI
OGUWS EUDAMEDFDA UDI
HGNA01S EUDAMEDFDA UDI
HOGUML EUDAMEDFDA UDI
OGZB01S EUDAMEDFDA UDI
HGSTRL EUDAMEDFDA UDI
OGIF02L EUDAMEDFDA UDI
OGZB02L EUDAMEDFDA UDI
HGBES EUDAMEDFDA UDI
OGAO02L EUDAMEDFDA UDI
HGIF01L EUDAMEDFDA UDI
OGSB01S EUDAMEDFDA UDI
OGTRS EUDAMEDFDA UDI
PGSPM EUDAMEDFDA UDI
HGIF02S EUDAMEDFDA UDI
HGNR03S EUDAMEDFDA UDI
OGSTRL EUDAMEDFDA UDI
OGAO01L EUDAMEDFDA UDI
HGZB02L EUDAMEDFDA UDI
OGIF01L EUDAMEDFDA UDI
HOGSRL EUDAMEDFDA UDI
OGIF02S EUDAMEDFDA UDI
OGSTRS EUDAMEDFDA UDI
OGUWL EUDAMEDFDA UDI
HGAO02S EUDAMEDFDA UDI
HGIF01S EUDAMEDFDA UDI
HGUMS EUDAMEDFDA UDI
HGSB01L EUDAMEDFDA UDI
HGNA01L EUDAMEDFDA UDI
OGSRS EUDAMEDFDA UDI
OGTRL EUDAMEDFDA UDI
OGNR03S EUDAMEDFDA UDI
HGURS EUDAMEDFDA UDI
OGNA02L EUDAMEDFDA UDI
OGNR01L EUDAMEDFDA UDI
OGTML EUDAMEDFDA UDI
OGNA01L EUDAMEDFDA UDI
HGIF02L EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
08800209367438 EUDAMEDFDA UDI
08809892361518 EUDAMEDFDA UDI
08809892361129 EUDAMEDFDA UDI
08800209367971 EUDAMEDFDA UDI
08809892361495 EUDAMEDFDA UDI
08800209370865 EUDAMEDFDA UDI
08800209367506 EUDAMEDFDA UDI
08809892361099 EUDAMEDFDA UDI
08809892361365 EUDAMEDFDA UDI
08800209367452 EUDAMEDFDA UDI
08800209367247 EUDAMEDFDA UDI
08809892361426 EUDAMEDFDA UDI
08809917108661 EUDAMEDFDA UDI
08800209367940 EUDAMEDFDA UDI
08809892361419 EUDAMEDFDA UDI
08800209367773 EUDAMEDFDA UDI
08800209367414 EUDAMEDFDA UDI
08809892361884 EUDAMEDFDA UDI
08800209367384 EUDAMEDFDA UDI
08800209370858 EUDAMEDFDA UDI
08809892361907 EUDAMEDFDA UDI
08800209367759 EUDAMEDFDA UDI
08809892361235 EUDAMEDFDA UDI
08809892361914 EUDAMEDFDA UDI
08800209367285 EUDAMEDFDA UDI
08809892361105 EUDAMEDFDA UDI
08800209367315 EUDAMEDFDA UDI
08809892361471 EUDAMEDFDA UDI
08809892361754 EUDAMEDFDA UDI
08809917109262 EUDAMEDFDA UDI
08800209367346 EUDAMEDFDA UDI
08800209367445 EUDAMEDFDA UDI
08809892361686 EUDAMEDFDA UDI
08809892361082 EUDAMEDFDA UDI
08800209367964 EUDAMEDFDA UDI
08809892361211 EUDAMEDFDA UDI
08800209370087 EUDAMEDFDA UDI
08809892361242 EUDAMEDFDA UDI
08809892361693 EUDAMEDFDA UDI
08809892361877 EUDAMEDFDA UDI
08800209367261 EUDAMEDFDA UDI
08800209367322 EUDAMEDFDA UDI
08800209367919 EUDAMEDFDA UDI
08800209367476 EUDAMEDFDA UDI
08800209367377 EUDAMEDFDA UDI
08809892361525 EUDAMEDFDA UDI
08809892361747 EUDAMEDFDA UDI
08809892361433 EUDAMEDFDA UDI
08800209367926 EUDAMEDFDA UDI
08809892361372 EUDAMEDFDA UDI
08809892361389 EUDAMEDFDA UDI
08809892361709 EUDAMEDFDA UDI
08809892361358 EUDAMEDFDA UDI
08800209367339 EUDAMEDFDA UDI
Basic UDI-DI
88000406CLASSIBS25V EUDAMED
FDA Product Code
NDP FDA UDI
EMDN Code
L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
GMDN Term
Surgical drill guide, reusable FDA UDI
Dental prosthesis/implant abutment screw analog, reusable FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Regulation Number
872.3980 FDA UDI
Market of Registration
Czechia EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Surgical drill guide, reusable

Guide by OSSTEM IMPLANT Co., Ltd. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Surgical drill guide, reusable.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
OSSTEM IMPLANT Co., Ltd.

Sources (108)

  • FDA UDI 8826e5e0-0855-49a0-ba8f-fa87892f2441 32 fields · synced Aug 3, 2026
  • FDA UDI 09d16d3c-1382-476d-95aa-bd0b980425e3 32 fields · synced May 27, 2026
  • FDA UDI 30ddd37b-94a2-4fec-a40b-f40a56a8db84 32 fields · synced May 27, 2026
  • FDA UDI c990bd2f-6ac2-413a-abd0-8b0176b2ac0f 32 fields · synced May 29, 2026
  • FDA UDI 1da7423f-b755-4372-b6b5-25af2db2e36c 32 fields · synced May 29, 2026
  • FDA UDI c01b01a1-0784-47cf-94e1-d84c527ab59e 32 fields · synced May 29, 2026
  • FDA UDI f7e783ae-667d-49e1-af90-a4a21c1254bb 32 fields · synced May 29, 2026
  • FDA UDI 00ebc11b-0dcd-4a11-80f4-9c1380c202d2 32 fields · synced May 29, 2026
  • FDA UDI 2418dff1-d421-4227-aecb-80715b4a8257 32 fields · synced May 29, 2026
  • FDA UDI d2188eee-bbac-40a8-871b-b68a0c8b3ce3 32 fields · synced May 29, 2026
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  • FDA UDI 29725823-9b26-4b37-b427-d0240be90571 32 fields · synced May 30, 2026
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  • FDA UDI 583d2bf3-1a5b-46b5-82a3-d6cde5fc9780 32 fields · synced May 30, 2026
  • FDA UDI 97816836-3135-4b41-8cc4-0d1bc8be254b 32 fields · synced May 30, 2026
  • FDA UDI c99e3f44-f131-4c31-a96d-86443fb5671c 32 fields · synced May 30, 2026
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  • FDA UDI 07012196-dc1b-490e-af9f-8086508aae36 32 fields · synced May 30, 2026
  • FDA UDI 521596d3-20a5-415a-8636-561534df7ce2 32 fields · synced May 30, 2026
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  • FDA UDI bd690745-5e34-41d3-a7fe-c2ce65f3e6e5 32 fields · synced May 30, 2026
  • FDA UDI 3f6e5556-ca56-4d23-adee-d2bc090a83dc 32 fields · synced May 30, 2026
  • FDA UDI b3afcf72-b0db-4627-a745-a0c59845575d 32 fields · synced May 30, 2026
  • FDA UDI e3f37102-7b0b-478a-ba8d-bd2af8bd62f0 32 fields · synced May 30, 2026
  • FDA UDI 54a02634-4e44-46ed-8044-9661de18103c 32 fields · synced May 30, 2026
  • FDA UDI cfec3165-803c-4dfa-acea-2982a6ba6d71 32 fields · synced May 30, 2026
  • FDA UDI 9410647a-aa41-4755-a345-023d542cb6de 32 fields · synced May 30, 2026
  • FDA UDI 9a6c4222-31a0-4770-a4ff-8f84f13689cb 32 fields · synced May 30, 2026
  • FDA UDI fc49a847-1543-4237-b142-742faf837ddf 32 fields · synced May 30, 2026
  • EUDAMED 00f4811f-39dd-4c1e-a8d4-f9f35ba3f37b 61 fields · synced Jun 20, 2026
  • EUDAMED a7b994c8-f0f8-4f7b-a459-35bc12c8d68b 61 fields · synced Jul 8, 2026
  • EUDAMED d5ed20c4-aac0-4899-84bb-601ad01b2e79 61 fields · synced Jul 9, 2026
  • EUDAMED 744d56f1-800d-4f3b-ad26-f90617f09fa0 61 fields · synced Jul 9, 2026
  • EUDAMED f60253ba-d0ad-4714-8b5c-e91fe28bb2de 61 fields · synced Jul 9, 2026
  • EUDAMED e4445315-385b-49fd-a81d-d8ccd1e0021e 61 fields · synced Jul 9, 2026
  • EUDAMED 3d049f4f-5386-44a1-9d61-7ef57729ba92 61 fields · synced Jul 9, 2026
  • EUDAMED e7aa63f2-8391-41ce-976f-21557178ae9c 61 fields · synced Jul 10, 2026
  • EUDAMED 1a3a06d5-e06f-491d-a537-137b3f816b50 61 fields · synced Jul 10, 2026
  • EUDAMED 13a2a6c0-0a50-4ee9-b6f2-f35fab7f70bc 61 fields · synced Jul 10, 2026
  • EUDAMED 58c481bf-9898-418c-a219-959020cf0a56 61 fields · synced Jul 10, 2026
  • EUDAMED bd78bee0-be30-422c-b4ef-4f2242de7484 61 fields · synced Jul 10, 2026
  • EUDAMED 9a5252d4-2993-46a3-90a0-a5daf6adc36c 61 fields · synced Jul 11, 2026
  • EUDAMED 1ade1c20-6445-48de-89db-cbfe34d2f6c2 61 fields · synced Jul 11, 2026
  • EUDAMED fd6ca7b0-5ecd-4428-a488-8945baf6dfb2 61 fields · synced Jul 11, 2026
  • EUDAMED e19a933a-2ddd-487b-9a1f-be2c91bb64a3 61 fields · synced Jul 12, 2026
  • EUDAMED b8515381-8ea4-4ed6-9ce6-0ce5269655f1 61 fields · synced Jul 12, 2026
  • EUDAMED 8f67b66c-079b-4a1c-8266-d2f72ecad0d5 61 fields · synced Jul 13, 2026
  • EUDAMED f943d74f-ea9d-48cd-bca4-fd1d5b52c9bb 61 fields · synced Jul 13, 2026
  • EUDAMED 6f98ea3d-387f-4198-a219-0f66ba83c5f0 61 fields · synced Jul 13, 2026
  • EUDAMED 79f0cb7d-34a6-4a81-8c42-dac7b6a1b270 61 fields · synced Jul 13, 2026
  • EUDAMED 5a394ff7-d64d-4869-bbc9-2f5cb3a64b6a 61 fields · synced Jul 14, 2026
  • EUDAMED f8d1a19f-2657-4024-a9a5-e3f8fe2d0285 61 fields · synced Jul 14, 2026
  • EUDAMED 5214d079-7e87-4871-8119-4de4e795b92f 61 fields · synced Jul 14, 2026
  • EUDAMED b0aaf75e-4f8c-475f-807e-5cb86540ab41 61 fields · synced Jul 14, 2026
  • EUDAMED d94676d3-a8b7-435b-9b1b-cf4328f24912 61 fields · synced Jul 15, 2026
  • EUDAMED e73bf209-aa04-49ac-8e8a-731b30679322 61 fields · synced Jul 15, 2026
  • EUDAMED 87476534-7044-42f6-bd92-de1d0c693ae8 61 fields · synced Jul 16, 2026
  • EUDAMED f9da19ef-a50e-42d4-9173-41b1c6cfeb6f 61 fields · synced Jul 17, 2026
  • EUDAMED 5182532b-6635-431b-bfc1-0b161962208e 61 fields · synced Jul 18, 2026
  • EUDAMED 9f31228f-304b-448a-a884-26d9d541c697 61 fields · synced Jul 19, 2026
  • EUDAMED d0be88bd-28ef-4300-ab23-80f175bdb98d 61 fields · synced Jul 20, 2026
  • EUDAMED 345e8be1-a59b-4ce6-b79d-2be9c530a294 61 fields · synced Jul 21, 2026
  • EUDAMED 30d5ff50-6597-4269-b412-d831e62e83ba 61 fields · synced Jul 21, 2026
  • EUDAMED c8dbc6bc-9cfa-4ebb-b7f8-28bbdc16ab13 61 fields · synced Jul 21, 2026
  • EUDAMED ee95f9a0-2c1a-4686-abfb-d731223a57b2 61 fields · synced Jul 22, 2026
  • EUDAMED 19f0f52c-c802-44f5-9a2e-17e429a69d11 61 fields · synced Jul 22, 2026
  • EUDAMED f4ddd55d-96b4-4562-a1da-92ca7dffcf1f 61 fields · synced Jul 23, 2026
  • EUDAMED 3acf4602-24b8-445a-853e-c0f0f80a2ded 61 fields · synced Jul 23, 2026
  • EUDAMED ccf63173-aaf3-4004-9896-5c06a790e1d5 61 fields · synced Jul 25, 2026
  • EUDAMED a95bdac4-0212-4b95-ad51-e9fec76d6888 61 fields · synced Jul 25, 2026
  • EUDAMED e5db64fc-c330-42c5-b01f-4ea76790bf6f 61 fields · synced Jul 25, 2026
  • EUDAMED 1f6f2e11-c839-4b89-b4b5-cc2d478e0962 61 fields · synced Jul 26, 2026
  • EUDAMED d614c778-bb6d-4667-8104-b5416d8eb976 61 fields · synced Jul 26, 2026
  • EUDAMED 0fc5841a-7c7e-49e0-b384-51b2c6293b12 61 fields · synced Jul 26, 2026
  • EUDAMED 3c1cecbe-d700-42df-a278-89047ecbedda 61 fields · synced Jul 28, 2026
  • EUDAMED af39523a-43b8-4f77-b8a5-fe4ef58e502c 61 fields · synced Jul 28, 2026
  • EUDAMED ae39a32c-2c36-4212-9b7e-af187017249e 61 fields · synced Jul 28, 2026
  • EUDAMED 557688c7-f3a7-4687-93cc-66e07f1097ff 61 fields · synced Jul 28, 2026
  • EUDAMED 7937af19-3531-48a5-baf0-afea2d933ab5 61 fields · synced Jul 28, 2026
  • EUDAMED 833be22c-b1bf-46d5-b75e-ff518ddb32af 61 fields · synced Jul 29, 2026
  • EUDAMED 77dffb29-ef46-408a-bde4-898d2fa90001 61 fields · synced Jul 29, 2026
  • EUDAMED 00909a92-1aab-43ad-9c45-f48cc066f2c1 61 fields · synced Aug 2, 2026
  • EUDAMED 4e2494af-8958-4c90-86a5-dea578ccf5d8 61 fields · synced Aug 3, 2026