FDA UDI
In Commercial Distribution
🇺🇸 United States
Ambler Surgical
DI: 00190660215446
·
Model: Duet-style MICS Hoffman/Ahmed vertical scissors
·
AMBLER SURGICAL CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Ambler Surgical
- Primary DI
- 00190660215446
- Version / Model
- Duet-style MICS Hoffman/Ahmed vertical scissors
- Catalog Number
- 6106E
- Company Name
- AMBLER SURGICAL CORP.
- Labeler DUNS
- 015272206
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-07
- Public Version
- 1
- Public Version Date
- 2021-01-15
- Public Version Status
- New
- Public Device Record Key
- 057f122f-f847-4106-8979-4b340d3f3cd2
Device Description
Duet-style MICS Hoffman/Ahmed vertical scissors, 1 3/8'', 21 gauge, curved shaft, for use with Ambler #6100T
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HNF | SCISSORS, OPHTHALMIC | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63555 | Intraocular scissors probe-tip, reusable | A distal component of a probe-like intraocular scissors assembly intended to be used to cut intraocular tissue (e.g., during anterior chamber surgery, vitrectomy). It is a probe-/cannula-like shaft with two shearing blades at the end, and is intended to be attached to an appropriate ophthalmic surgical instrument handle (not included). It is available with various blade designs and sizes. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00190660215446 | GS1 |
Customer Contacts
- Phone
- +1(888)407-0006 ext. 0
- [email protected]