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Lone Star
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 3311-8GModel 3611Ref 3304GModel 3707Ref 3205-8GRef 91167705-01Ref 3704Ref 3302GRef 3330-4GRef 3308GRef 1107Model 1104Ref 3316-1GRef 3314-8GRef 3331-4GRef 3314-1GRef 3329-4GRef 3325-4GRef 3307GRef 2200Ref 3334-4G
Identity
- Trade Name
- Lone Star® EUDAMEDLone Star FDA UDILone Star Reusable Retractor Ring FDA UDI
- Generic Name
- Surgical retractor/retraction system blade, single-use FDA UDISurgical retraction system mounting frame, single-use FDA UDIRadial surgical retractor FDA UDISurgical retraction system mounting frame, reusable FDA UDI
- Device Name
- Lone Star Scroto-Pak™ EUDAMEDLone Star® Retractor System™ EUDAMEDLone Star® Retractors (Reusable) EUDAMEDLone Star Elastic Stays - 5mm Elastic stays 8/ Pk FDA UDILone Star Disposable retractor ring with 2 catheter clips ; 32.5 cm x 18.3 cm FDA UDILone Star Elastic stays - Pro-Stay 8/Pak FDA UDILone Star Elastic Stays - 3 mm Elastic stays 8/ Pk FDA UDILone Star Elastic Stays - 3mm Elastic stays 50/CS FDA UDILoneStar Disposable Retractor Ring with 2 catheter clips - 28.3 cm x 18.3 cm FDA UDILoneStar Disposable Retractor Ring (Sterile) - 14.1 cm x 14.1 cm FDA UDILone Star Retractor System Gynecology kit, Box of 5 FDA UDILone Star Solid blade Long Stays FDA UDI5 mm Elastic Stays, Blunt FDA UDILone Star Reusable Retractor Ring Aluminum • Small Square • 14.5 cm x 14.5 cm (206 g) FDA UDILone Star Solid blade Stays - 4/PK FDA UDILone Star Elastic Stays - 5 mm 2 finger Elastic stays FDA UDILone Star 4-Finger Stays 4/PK FDA UDILone Star Disposable Retractor Ring - 22.0 cm x 11.3 cm FDA UDIElastic Stays 12mm; Blunt hook FDA UDILone Star Elastic Stays - 9 mm 2 finger Elastic stays FDA UDICantilever Retractor- Large FDA UDI
- Model / Reference
- 3311-8G EUDAMEDFDA UDI3304G EUDAMEDFDA UDI3205-8G EUDAMEDFDA UDI3314-8G EUDAMEDFDA UDI3314-1G EUDAMEDFDA UDI3308G EUDAMEDFDA UDI3307G EUDAMEDFDA UDI3704 EUDAMEDFDA UDI3331-4G EUDAMEDFDA UDI3316-1G EUDAMEDFDA UDI1107 EUDAMEDFDA UDI3330-4G EUDAMEDFDA UDI3325-4G EUDAMEDFDA UDI3334-4G EUDAMEDFDA UDI3302G EUDAMEDFDA UDI91167705-01 EUDAMEDFDA UDI3329-4G EUDAMEDFDA UDI2200 EUDAMEDFDA UDI3611 EUDAMED3707 EUDAMED1104 EUDAMED
- Description
- Lone Star Elastic Stays - 5mm Elastic stays 8/ Pk FDA UDILone Star Disposable retractor ring with 2 catheter clips ; 32.5 cm x 18.3 cm FDA UDILone Star Elastic stays - Pro-Stay 8/Pak FDA UDILone Star Elastic Stays - 3 mm Elastic stays 8/ Pk FDA UDILone Star Elastic Stays - 3mm Elastic stays 50/CS FDA UDILoneStar Disposable Retractor Ring with 2 catheter clips - 28.3 cm x 18.3 cm FDA UDILoneStar Disposable Retractor Ring (Sterile) - 14.1 cm x 14.1 cm FDA UDILone Star Retractor System Gynecology kit, Box of 5 FDA UDILone Star Solid blade Long Stays FDA UDI5 mm Elastic Stays, Blunt FDA UDILone Star Reusable Retractor Ring Aluminum • Small Square • 14.5 cm x 14.5 cm (206 g) FDA UDILone Star Solid blade Stays - 4/PK FDA UDILone Star Elastic Stays - 5 mm 2 finger Elastic stays FDA UDILone Star 4-Finger Stays 4/PK FDA UDILone Star Disposable Retractor Ring - 22.0 cm x 11.3 cm FDA UDIElastic Stays 12mm; Blunt hook FDA UDILone Star Elastic Stays - 9 mm 2 finger Elastic stays FDA UDICantilever Retractor- Large FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888937015485 EUDAMEDFDA UDI00888937015362 EUDAMEDFDA UDI00888937015461 EUDAMEDFDA UDI00888937015508 EUDAMEDFDA UDI00888937015492 EUDAMEDFDA UDI00888937015386 EUDAMEDFDA UDI00888937015379 EUDAMEDFDA UDI00888937015423 EUDAMEDFDA UDI00888937015577 EUDAMEDFDA UDI00888937015515 EUDAMEDFDA UDI00888937015300 EUDAMEDFDA UDI00888937015560 EUDAMEDFDA UDI00888937015539 EUDAMEDFDA UDI00888937015607 EUDAMEDFDA UDI00888937015355 EUDAMEDFDA UDI00888937015010 EUDAMEDFDA UDI00888937015553 EUDAMEDFDA UDI00888937015324 EUDAMEDFDA UDI
- Basic UDI-DI
- 0888937TD0692A EUDAMED0888937TD007sYJ EUDAMED0888937TD007rYG EUDAMED
- FDA Product Code
- GAD FDA UDI
- EMDN Code
- V9012 NON-SPECIALIST SURGICAL INSTRUMENTS AND KITS, SINGLE-USE EUDAMED
- GMDN Term
- Surgical retractor/retraction system blade, single-use FDA UDISurgical retraction system mounting frame, single-use FDA UDIRadial surgical retractor FDA UDISurgical retraction system mounting frame, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDIClass IIa EUDAMED
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDIEUDAMEDFDA UDI
Single Use
Yes
FDA UDIFDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMEDEUDAMED
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 UDIFDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDIFDA UDI
Lot / Batch Number
Yes
FDA UDIFDA UDI
Serial Number
No
FDA UDIFDA UDI
Expiration Date
Yes
FDA UDIFDA UDI
Manufacturing Date
No
FDA UDIFDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Tip Bend Radius — 5 Millimeter FDA UDIOuter Diameter — 32.5 Centimeter FDA UDIOuter Diameter — 18.3 Centimeter FDA UDITip Bend Radius — 3 Millimeter FDA UDIOuter Diameter — 28.3 Centimeter FDA UDIOuter Diameter — 14.1 Centimeter FDA UDIOuter Diameter — 25 Centimeter FDA UDILength — 13 Millimeter FDA UDIWidth — 20 Millimeter FDA UDIWidth — 16 Millimeter FDA UDILength — 20 Millimeter FDA UDIOuter Diameter — 22 Centimeter FDA UDIOuter Diameter — 11.3 Centimeter FDA UDITip Bend Radius — 12 Millimeter FDA UDITip Bend Radius — 9 Millimeter FDA UDIOuter Diameter — 27.5 Centimeter FDA UDIOuter Diameter — 18.4 Centimeter FDA UDIWeight — 795 Gram FDA UDI
Category: Surgical retractor/retraction system blade, single-use
Lone Star by CooperSurgical, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- CooperSurgical, Inc.
Sources (36)
- FDA UDI c9e151a9-adfe-4d85-be56-b43f64640565 34 fields · synced Aug 2, 2026
- FDA UDI 79bd6ccb-13a8-4971-8e66-7a9000a865ae 34 fields · synced May 24, 2026
- FDA UDI 1f2810c2-532b-4c4a-925c-d23f917f24ab 34 fields · synced May 24, 2026
- FDA UDI ce778e6a-ad98-4433-ba7d-77623e13451b 34 fields · synced May 24, 2026
- FDA UDI 4a481f0b-a0bc-43f0-b16d-77fe12aa4691 34 fields · synced May 26, 2026
- FDA UDI 4251716b-0ffe-4d61-8a86-d631bfd68d07 34 fields · synced May 27, 2026
- FDA UDI 7625c8ca-6abf-4454-9052-eedaa9db5531 34 fields · synced May 29, 2026
- FDA UDI 73abc5aa-77d6-4df3-a80a-35ccf86f6f10 34 fields · synced May 29, 2026
- FDA UDI ed71c371-1ab6-4a1a-9973-b0682495f315 34 fields · synced May 30, 2026
- FDA UDI bd3eff66-38c8-46e3-9a77-e3b495fa883e 33 fields · synced May 30, 2026
- FDA UDI 0bb24228-a47e-46e5-bd77-308a4e02c19b 33 fields · synced May 30, 2026
- FDA UDI eb5f5859-2c41-4b52-af71-a42418e2a9f8 34 fields · synced May 30, 2026
- FDA UDI b24fc126-63aa-42c8-b4e3-a2a50a9bd66e 34 fields · synced May 30, 2026
- FDA UDI 74594ce0-f093-4998-b8a4-3cecd3b78a32 34 fields · synced May 30, 2026
- FDA UDI 00b42f28-706a-4006-ad86-3e4e82a92563 34 fields · synced May 30, 2026
- FDA UDI 2ff71ec2-fcd9-4452-b67c-d933dbb9c286 34 fields · synced May 30, 2026
- FDA UDI 294af6ae-f860-4f6d-a547-82db244ce468 34 fields · synced May 30, 2026
- FDA UDI 80f8e0e5-928c-4950-943f-1468537052a1 34 fields · synced May 30, 2026
- EUDAMED ac68eb30-4635-4b67-948d-448c5603f19a 61 fields · synced Jul 8, 2026
- EUDAMED 37948965-8efb-4cae-907e-3d660d009ebd 61 fields · synced Jul 9, 2026
- EUDAMED 2fed00b4-e824-4750-8819-6e13c9196bff 61 fields · synced Jul 9, 2026
- EUDAMED 42960742-9858-4e73-8391-553357e4ab54 61 fields · synced Jul 9, 2026
- EUDAMED 29e25252-ec73-4fd7-ae25-b8f54822595d 61 fields · synced Jul 11, 2026
- EUDAMED 0fe764e6-0e1d-44b4-be7f-7e1478eef382 61 fields · synced Jul 11, 2026
- EUDAMED e7b50dda-3113-4d09-bea3-22df89315231 61 fields · synced Jul 11, 2026
- EUDAMED 96f91f4d-ad94-42e3-8047-67fe64b28f5a 61 fields · synced Jul 12, 2026
- EUDAMED 851664ff-4f2a-4f0b-95a0-93faa24a3f46 61 fields · synced Jul 12, 2026
- EUDAMED 17a448a1-e7bf-43a6-b2c8-8995fcb1f8c7 61 fields · synced Jul 12, 2026
- EUDAMED 1eb81c9e-1c52-4264-a7ca-cb6a7c896c25 61 fields · synced Jul 13, 2026
- EUDAMED 673c66c7-42cd-4ee7-8222-0fe8ceb814b1 61 fields · synced Jul 19, 2026
- EUDAMED 22b933a3-83e5-4056-b969-3293559dce55 61 fields · synced Jul 28, 2026
- EUDAMED 68957b7c-5b69-4014-90a4-c34c9d85fa66 61 fields · synced Jul 29, 2026
- EUDAMED 8f976013-3caf-4623-a945-1ca067f3c948 61 fields · synced Jul 31, 2026
- EUDAMED ce7bc5ad-cc73-4ab2-a05d-02e7949223a6 61 fields · synced Aug 1, 2026
- EUDAMED 74ab14e0-6343-4e09-ac2d-d3180afa2497 61 fields · synced Aug 2, 2026
- EUDAMED 38e35acb-d2c1-4cb4-b33c-623a8adf92fc 61 fields · synced Aug 2, 2026