FDA UDI
In Commercial Distribution
🇺🇸 United States
Integra® Jarit®
DI: 10381780201397
·
Model: 475162
·
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Integra® Jarit®
- Primary DI
- 10381780201397
- Version / Model
- 475162
- Catalog Number
- 475-162
- Company Name
- INTEGRA LIFESCIENCES PRODUCTION CORPORATION
- Labeler DUNS
- 081277700
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-16
- Public Version
- 5
- Public Version Date
- 2023-04-18
- Public Version Status
- Update
- Public Device Record Key
- 6331e1f2-cc89-4c6a-926b-72025fce00e7
Device Description
Integra® Jarit® Brinkerhoff Rectal Speculum, Medium, 3-7/8" Deep
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 |
|---|---|---|---|---|
| FFQ | SPECULUM, RECTAL | Gastroenterology, Urology | 876.4730 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35351 | Rectal speculum | A hand-held manual surgical instrument intended to be used to expand or stretch the rectal orifice/canal after it is inserted and opened. It is comprised of two arms joined at a pivot point and is available in various sizes, shapes, and contours; it is usually made of stainless steel. The instrument is used for examination or for the insertion of other instrumentation. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Secondary | M2744751621 | HIBCC | ||||
| Primary | 10381780201397 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- No