Identity
- Trade Name
- CODMAN® FDA UDI
- Generic Name
- Neurosurgical sponge FDA UDI
- Device Name
- CODMAN® Bulk Surgical Strips X-Ray Detectable 1/4" x 6" (6mm x 152mm) FDA UDI
- Model / Reference
- 245431 FDA UDI
- Description
- CODMAN® Bulk Surgical Strips X-Ray Detectable 1/4" x 6" (6mm x 152mm) FDA UDI
Identifiers
- Catalog Number
- 24-5431 FDA UDI
- Primary DI / UDI-DI
- 10381780513469 FDA UDI
- 510(k) Number
- K193346 FDA UDI
- FDA Product Code
- HBA FDA UDI
- GMDN Term
- Neurosurgical sponge FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4700 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Ethylene Oxide FDA UDI
Category: Neurosurgical sponge
Codman® by Integra LifeSciences Production Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Neurosurgical sponge.
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- Delicot — American Surgical Company, LLC · Class II
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- Delicot — American Surgical Company, LLC · Class II
- FABCO — FIRST AID BANDAGE CO INC · U
- ArmourSorb — American Surgical Company, LLC · Class II
- FABCO — FIRST AID BANDAGE CO INC · U
Cleared under the same submission
K193346 also covers:
- CODMAN® — Integra LifeSciences Production Corporation
- CODMAN® — Integra LifeSciences Production Corporation
- CODMAN® — Integra LifeSciences Production Corporation
- MEDLINE INDUSTRIES, INC. — MEDLINE INDUSTRIES, INC.
- Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.
- Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.
- Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.
- Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Integra LifeSciences Production Corporation
Sources (1)
- FDA UDI 8f216902-e03a-42ae-b7a6-9db7382ba8f5 37 fields · synced Jun 9, 2026