FDA UDI
In Commercial Distribution
🇺🇸 United States
Tech Medical Services
DI: 00851695005289
·
Model: TMMD233050
·
TECHMEDICAL SERVICES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Tech Medical Services
- Primary DI
- 00851695005289
- Version / Model
- TMMD233050
- Company Name
- TECHMEDICAL SERVICES, INC.
- Labeler DUNS
- 556093219
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-27
- Public Version
- 1
- Public Version Date
- 2021-07-05
- Public Version Status
- New
- Public Device Record Key
- 93704914-1890-4fb4-b261-e2c0a332af5a
Device Description
Maryland Dissecting Grasper, 5mm/33cm
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61839 | Rigid endoscopic tissue manipulation forceps, single-use | A rigid, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope and/or an endoscopic port (e.g., laparoscopic port) primarily for grasping and manipulating tissues during endoscopic surgery. It has proximal controls (e.g., scissors-like handles), a rigid long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10851695005286 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 00851695005289 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K103508 | 000 |