FDA UDI
In Commercial Distribution
🇺🇸 United States
Lead Loop
DI: M759CATTFD01
·
Model: CAT-TFD-10
·
Suture Concepts Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Lead Loop
- Primary DI
- M759CATTFD01
- Version / Model
- CAT-TFD-10
- Catalog Number
- CAT-TFD-10
- Company Name
- Suture Concepts Inc.
- Labeler DUNS
- 079749303
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-04-25
- Public Version
- 1
- Public Version Date
- 2018-05-28
- Public Version Status
- New
- Public Device Record Key
- 109a06cc-1145-4715-b9d1-a08494de868c
Device Description
Suture Concepts Trail Lead Fixation Device
Device Characteristics
- Single Use
- Yes
- 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
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KGX | Tape And Bandage, Adhesive | General Hospital | 880.5240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58484 | Multi-purpose surgical adhesive tape, sterile | A long thin band of sterile synthetic material coated on one side with a pressure-sensitive adhesive, intended to be used for a variety of surgical/clinical intervention external taping applications [e.g., draping a patient for surgery and /or creating a window around a site of intervention, creating a sterile barrier, fixing/sealing items to a patient (e.g., a stockinette), managing/organizing tubing, cables, and other operating room (OR) devices]. It is typically made of a plastic material or combination of materials. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M759CATTFD01 | HIBCC |
Customer Contacts
- Phone
- 9789690070
- [email protected]