Identity
- Trade Name
- PILLING FDA UDI
- Generic Name
- Dissection sponge FDA UDI
- Device Name
- SPONGE CYLINDRICAL STERILE 1/2" X1 1/2" END-STRUNG 100/ BOX FDA UDI
- Model / Reference
- IPN004275 FDA UDI
- Description
- SPONGE CYLINDRICAL STERILE 1/2" X1 1/2" END-STRUNG 100/ BOX FDA UDI
Identifiers
- Catalog Number
- 200402 FDA UDI
- Primary DI / UDI-DI
- 04026704417889 FDA UDI
- 510(k) Number
- K913302 FDA UDI
- FDA Product Code
- GDY FDA UDI
- GMDN Term
- Dissection sponge FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4450 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Width — 58 Millimeter FDA UDILength — 86 Millimeter FDA UDI
Category: Dissection sponge
Pilling by Teleflex Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K913302 also covers:
- PILLING — TELEFLEX INCORPORATED
- PILLING — TELEFLEX INCORPORATED
- PILLING — TELEFLEX INCORPORATED
- PILLING — TELEFLEX INCORPORATED
- PILLING — TELEFLEX INCORPORATED
- PILLING — TELEFLEX INCORPORATED
- PILLING — TELEFLEX INCORPORATED
- PILLING — TELEFLEX INCORPORATED
- PILLING — TELEFLEX INCORPORATED
- PILLING — TELEFLEX INCORPORATED
- PILLING — TELEFLEX INCORPORATED
- PILLING — TELEFLEX INCORPORATED
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Teleflex Incorporated
Sources (1)
- FDA UDI 005d47b9-eec6-4b2f-bda1-853c80b57058 37 fields · synced Jun 8, 2026