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SCANLAN Minimally-Invasive Instrumentation

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 9909-214Ref 9909-915Ref 9909-914Ref 9909-227Ref Q28016-9Ref 9909-222Ref 9909-225Ref 9009-241Ref 9909-913

by Scanlan International Inc

Identity

Trade Name
SCANLAN Minimally-Invasive Instrumentation FDA UDI
SCANLAN® Minimally Invasive Instrument FDA UDI
SCANLAN® Thoracoscopic DeBakey Clamp FDA UDI
SCANLAN® Minimally-Invasive Instrumentation FDA UDI
SCANLAN® FDA UDI
Generic Name
Rigid endoscopic tissue manipulation forceps, reusable FDA UDI
Device Name
SCANLAN® CardioVasive™ /Thoracoscopic DeBakey Clamp EUDAMED
SCANLAN® Thoracoscopic DeBakey Clamp EUDAMED
Thoracoscopic Chitwood DeBakey Clamp, 10mm, RngHdl,1x2 CurvLft 7cm DeBak Jaws, 6 3/4" / 17cm FDA UDI
Thoracoscopic DeBakey Clamp, 10 mm, Harken #2, Ring Handle, 1 x 2 wide DeBakey jaws, with ratchet, 9.5 cm jaw length, 24.8 cm working length, 14" / 35.5 cm FDA UDI
CardioVasive™ Thoracoscopic DeBakey Clamp (10 mm), 45 degree angled left jaw, (10.5 cm jaw length; 27 cm working length), 14" / 35.5 cm FDA UDI
Thoracoscopic Chitwood DeBakey Clamp,10mm, rnghdl,1x2 curvlft 7cm DeBak jaws,ang shks,6 3/4" FDA UDI
Thoracoscopic DeBakey Clamp, 10 mm, ring handle, 1x2 straight jaw FDA UDI
Thoracoscopic Chitwood DeBakey Clamp,10mm, rnghdl,1x2 curv rt 7 cm DeBak jaws,10 3/8" / 26.4cm FDA UDI
Thoracoscopic DeBakey Clamp, 10 mm, Harken #1, ring handle, 1x2 wide DeBakey jaws, with ratchet, 9.5 cm jaw length, 24.8 cm working length 14" / 35.5 cm FDA UDI
Thoracoscopic DeBakey Clamp FDA UDI
Model / Reference
9909-914 EUDAMEDFDA UDI
9909-227 EUDAMEDFDA UDI
9909-214 EUDAMEDFDA UDI
9909-913 EUDAMEDFDA UDI
9909-222 EUDAMEDFDA UDI
9909-915 EUDAMEDFDA UDI
9909-225 EUDAMEDFDA UDI
9009-241 EUDAMEDFDA UDI
Q28016-9 EUDAMED
Description
Thoracoscopic Chitwood DeBakey Clamp, 10mm, RngHdl,1x2 CurvLft 7cm DeBak Jaws, 6 3/4" / 17cm FDA UDI
Thoracoscopic DeBakey Clamp, 10 mm, Harken #2, Ring Handle, 1 x 2 wide DeBakey jaws, with ratchet, 9.5 cm jaw length, 24.8 cm working length, 14" / 35.5 cm FDA UDI
CardioVasive™ Thoracoscopic DeBakey Clamp (10 mm), 45 degree angled left jaw, (10.5 cm jaw length; 27 cm working length), 14" / 35.5 cm FDA UDI
Thoracoscopic Chitwood DeBakey Clamp,10mm, rnghdl,1x2 curvlft 7cm DeBak jaws,ang shks,6 3/4" FDA UDI
Thoracoscopic DeBakey Clamp, 10 mm, ring handle, 1x2 straight jaw FDA UDI
Thoracoscopic Chitwood DeBakey Clamp,10mm, rnghdl,1x2 curv rt 7 cm DeBak jaws,10 3/8" / 26.4cm FDA UDI
Thoracoscopic DeBakey Clamp, 10 mm, Harken #1, ring handle, 1x2 wide DeBakey jaws, with ratchet, 9.5 cm jaw length, 24.8 cm working length 14" / 35.5 cm FDA UDI
Thoracoscopic DeBakey Clamp FDA UDI

Identifiers

Catalog Number
9909-914 FDA UDI
9909-227 FDA UDI
9909-214 FDA UDI
9909-913 FDA UDI
9909-222 FDA UDI
9909-915 FDA UDI
9909-225 FDA UDI
9009-241 FDA UDI
Primary DI / UDI-DI
00846159028843 EUDAMEDFDA UDI
00846159012842 EUDAMEDFDA UDI
00846159026191 EUDAMEDFDA UDI
00846159025507 EUDAMEDFDA UDI
00846159011661 EUDAMEDFDA UDI
00846159025491 EUDAMEDFDA UDI
00846159012231 EUDAMEDFDA UDI
00846159025712 EUDAMEDFDA UDI
00846159039412 EUDAMED
Basic UDI-DI
B-00846159026191 EUDAMED
B-00846159025491 EUDAMED
B-00846159028843 EUDAMED
B-00846159012842 EUDAMED
B-00846159039412 EUDAMED
B-00846159011661 EUDAMED
B-00846159012231 EUDAMED
B-00846159025712 EUDAMED
B-00846159025507 EUDAMED
510(k) Number
K945474 FDA UDI
FDA Product Code
GCJ FDA UDI
EMDN Code
L031306 HEMOSTATIC FORCEPS, REUSABLE EUDAMED
GMDN Term
Rigid endoscopic tissue manipulation forceps, reusable FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Rigid endoscopic tissue manipulation forceps, reusable

SCANLAN Minimally-Invasive Instrumentation by Scanlan International Inc — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Rigid endoscopic tissue manipulation forceps, reusable.

Cleared under the same submission

K945474 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Scanlan International Inc

Sources (17)

  • FDA UDI 5a6b8859-6ae5-41a3-8fc7-6b6c89cff3f7 36 fields · synced Sep 30, 2026
  • FDA UDI aec3afef-12f6-434f-87db-0846c2bf2a6c 36 fields · synced May 30, 2026
  • FDA UDI 5223da52-019a-42b3-89b9-14e769759ff6 36 fields · synced May 30, 2026
  • FDA UDI a3e5a725-f486-4bd9-bc8d-8e02533f10ee 36 fields · synced May 30, 2026
  • FDA UDI 26200657-f243-4d67-b18e-c9175ee16509 36 fields · synced May 30, 2026
  • FDA UDI c5dab493-211d-48d8-9fda-c6f2dd1e2470 36 fields · synced May 30, 2026
  • FDA UDI c5904c0d-1394-44c2-a604-ad085dc3683b 36 fields · synced May 30, 2026
  • FDA UDI 587e1a09-c1da-4cde-9d6c-e8f02e6dee86 36 fields · synced May 30, 2026
  • EUDAMED 767ce2b5-3499-445f-a4b4-c53ebad7c0dc 61 fields · synced Jun 18, 2026
  • EUDAMED ae01987d-4dce-4bb2-8f8b-53631bf40b8c 61 fields · synced Jul 9, 2026
  • EUDAMED 5a41934a-bd21-4228-96db-6385af51c140 61 fields · synced Jul 10, 2026
  • EUDAMED 31cef904-18e7-4c97-b731-b059e677d283 61 fields · synced Jul 10, 2026
  • EUDAMED 804aaf0f-756d-4d73-ae90-6b214ae37c38 61 fields · synced Jul 11, 2026
  • EUDAMED 17723fc6-05a0-4851-b8e5-b492c9a5eb32 61 fields · synced Jul 11, 2026
  • EUDAMED 0c43a658-d08f-4471-bc55-a8579b09f070 61 fields · synced Jul 14, 2026
  • EUDAMED 7fb893c6-7b3a-4bb5-9667-e9dc3084cb3a 61 fields · synced Jul 15, 2026
  • EUDAMED af0fa547-b01c-4ddd-892d-7d6bc5fe8fe6 61 fields · synced Sep 30, 2026