Identity
- Trade Name
- Baumgartner Needle Holder FDA UDI
- Generic Name
- Suturing needle holder, single-use FDA UDI
- Device Name
- Intended Use: Baumgartner Needle Holder is commonly used for holding long needles and dense suture material. Packaging: Packaging shall be as per customer requirements e.g set of 25 or set of 50. FDA UDI
- Model / Reference
- SU-13-0196-14 FDA UDI
- Description
- Intended Use: Baumgartner Needle Holder is commonly used for holding long needles and dense suture material. Packaging: Packaging shall be as per customer requirements e.g set of 25 or set of 50. FDA UDI
Identifiers
- Catalog Number
- SU-13-0196-14 FDA UDI
- Primary DI / UDI-DI
- G165SU130196140 FDA UDI
- FDA Product Code
- FHQ FDA UDI
- GMDN Term
- Suturing needle holder, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.4730 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Suturing needle holder, single-use
Baumgartner Needle Holder by Elmed Instruments(pvt)ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Elmed Instruments(pvt)ltd.
Sources (1)
- FDA UDI e2cbf62f-0dd9-4897-9434-a6c1a732e4cf 34 fields · synced May 31, 2026