FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Jaeger SS Lid Plate for the Laser (non glare), refurb.
DI: 10697660002047
·
Model: 21-295R
·
Oculo-Plastik Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Jaeger SS Lid Plate for the Laser (non glare), refurb.
- Primary DI
- 10697660002047
- Version / Model
- 21-295R
- Company Name
- Oculo-Plastik Inc
- Labeler DUNS
- 257382580
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-11-21
- Public Version
- 2
- Public Version Date
- 2022-03-25
- Public Version Status
- Update
- Public Device Record Key
- a1ab9683-1153-49d0-b728-d71903ea0a3f
- Distribution End Date
- 2022-03-24
Device Description
The Khan-Jaeger is a curved instrument partially non-glare for blepharoplasty. The usage of this instrument is to block laser beams, and retract the tissues during surgical intervention. It is used as a backstop or strip to press the tissue around the globe or press the globe itself. This technique makes the incision of the conjunctiva simpler and exposes the fat more easily. The polished part touches the ocular shield, which is inserted at the beginning of the procedure. The Khan-Jaeger has a more concave ergonomic design than the Jaeger, with the inside polished.
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| GAD | Retractor | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45918 | Hand-held surgical retractor, reusable | A hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10697660002047 | GS1 |
Customer Contacts
- Phone
- 514-381-3292
- [email protected]