Identity
- Trade Name
- HCS FDA UDI
- Generic Name
- Surgical sponge-counting bag FDA UDI
- Device Name
- 10” x 37.4” Sponge Counter Bag, Blue FDA UDI
- Model / Reference
- HCS7010B FDA UDI
- Description
- 10” x 37.4” Sponge Counter Bag, Blue FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00849027001139 FDA UDI
- FDA Product Code
- LWH FDA UDI
- GMDN Term
- Surgical sponge-counting bag FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.2740 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
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical sponge-counting bag
Hcs by Dyad Medical Sourcing, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical sponge-counting bag.
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- 50600 Sponge Counter Bags Clear — XODUS MEDICAL, INC. · Class I
- Medline — MEDLINE INDUSTRIES, INC. · Class I
- 50500 Sponge Counter Bag Blue — XODUS MEDICAL, INC. · Class I
- MediChoice — OWENS & MINOR DISTRIBUTION, INC. · Class I
- Medline — MEDLINE INDUSTRIES, INC. · Class I
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 |
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Manufacturer
- Manufacturer
- Dyad Medical Sourcing, Llc
Sources (1)
- FDA UDI e602d691-c31e-4345-b5a1-c0bb6df70efc 33 fields · synced May 30, 2026