FDA UDI
In Commercial Distribution
🇺🇸 United States
AutoLap Single Procedure Kit Pack (Ring, 10mm)
DI: 17290016648253
·
Model: ASS06510US
·
M.S.T. MEDICAL SURGERY TECHNOLOGIES LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- AutoLap Single Procedure Kit Pack (Ring, 10mm)
- Primary DI
- 17290016648253
- Version / Model
- ASS06510US
- Company Name
- M.S.T. MEDICAL SURGERY TECHNOLOGIES LTD
- Labeler DUNS
- 649827193
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-20
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 87d19851-1c52-4021-b99a-97c402468ded
Device Description
The Single Procedure Kit box contains: Ring unit- 1/box, Clippers set (10mm)- 1 set/box
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| 16240 | Laparoscope holder | A device intended to be used to hold, maintain in a desired position, and allow positional adjustment of, a laparoscope and associated instruments/devices during laparoscopy; it may also be intended to hold/position other surgical devices (e.g., retractors, manipulators) during other endoscopic or open surgical procedures. It typically consists of joints, rigid or semi-rigid arms, instrument holding and locking mechanisms, and a clamping mechanism for fixation to a stable object (e.g., the operating table). | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 17290016648253 | GS1 | ||||
| Package | 27290016648250 | GS1 | 6 | In Commercial Distribution |