FDA UDI
In Commercial Distribution
🇺🇸 United States
Stephens Instruments
DI: 00810799039293
·
Model: SSD1 1225
·
KRISHNA IMPORTS INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Stephens Instruments
- Primary DI
- 00810799039293
- Version / Model
- SSD1 1225
- Catalog Number
- SSD1 1225
- Company Name
- KRISHNA IMPORTS INC
- Labeler DUNS
- 081853285
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-23
- Public Version
- 1
- Public Version Date
- 2020-10-01
- Public Version Status
- New
- Public Device Record Key
- a4c55eee-9569-4933-bd82-facf71836efe
Device Description
Desmarres Lid Retractor #2, Single Use, 10/Box
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HNI | Retractor, ophthalmic | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64302 | Periocular/lacrimal retractor, hand-held, single-use | A hand-held, non-self-retaining, ophthalmic surgical instrument intended to be used to separate periocular tissues and/or draw aside the margins of a periocular surgical wound during an ophthalmic intervention (e.g., eyelid retraction, lacrimal sac access). The instrument is typically designed with a shaped/hooked blade or flat plate (e.g., eyelid plate) with a handle/holding portion, and is usually made of metal. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00810799039286 | GS1 | box | 10 | In Commercial Distribution | |
| Primary | 00810799039293 | GS1 |
Customer Contacts
- Phone
- +1(859)259-4925
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Room Temperature