Identity
- Trade Name
- Surgical Direct FDA UDI
- Generic Name
- Laparoscopic tissue manipulation forceps/working-channel FDA UDI
- Device Name
- 10mm 33cm Babcock Grasper, Insulated, Stainless Steel Handle, On/Off Ratchet, Flushport FDA UDI
- Model / Reference
- SD98283 FDA UDI
- Description
- 10mm 33cm Babcock Grasper, Insulated, Stainless Steel Handle, On/Off Ratchet, Flushport FDA UDI
Identifiers
- Catalog Number
- SD98283 FDA UDI
- Primary DI / UDI-DI
- B382SD982830 FDA UDI
- 510(k) Number
- K914910 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Laparoscopic tissue manipulation forceps/working-channel FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 33 Centimeter FDA UDIOuter Diameter — 10 Millimeter FDA UDI
Category: Laparoscopic tissue manipulation forceps/working-channel
Surgical Direct by Surgical Direct, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Laparoscopic tissue manipulation forceps/working-channel.
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- Ambler Surgical — Ambler Surgical, LLC · Class I
Cleared under the same submission
K914910 also covers:
- Signature — SILEX MEDICAL, LLC
- Signature — SILEX MEDICAL, LLC
- Signature — SILEX MEDICAL, LLC
- Signature — SILEX MEDICAL, LLC
- Signature — SILEX MEDICAL, LLC
- Signature — SILEX MEDICAL, LLC
- Signature — SILEX MEDICAL, LLC
- Signature — SILEX MEDICAL, LLC
- Signature — SILEX MEDICAL, LLC
- Signature — SILEX MEDICAL, LLC
- Signature — SILEX MEDICAL, LLC
- Signature — SILEX MEDICAL, LLC
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 |
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Manufacturer
- Manufacturer
- Surgical Direct, Inc.
Sources (1)
- FDA UDI cab3c7f1-8868-49b3-ab5c-a4c995ce8b29 37 fields · synced Jun 1, 2026