FDA UDI
In Commercial Distribution
🇺🇸 United States
Single Use Sterile Saline Breast Implant Sizer for Natrelle Style 68 LP
DI: M746SZLP682000
·
Model: SZLP68200
·
SPECIALTY SURGICAL PRODUCTS INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Single Use Sterile Saline Breast Implant Sizer for Natrelle Style 68 LP
- Primary DI
- M746SZLP682000
- Version / Model
- SZLP68200
- Catalog Number
- SZLP68200
- Company Name
- SPECIALTY SURGICAL PRODUCTS INC
- Labeler DUNS
- 002112626
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-01
- Public Version
- 5
- Public Version Date
- 2020-12-21
- Public Version Status
- Update
- Public Device Record Key
- 8a8acb49-978d-4a8f-b3f7-85edb3c9a744
Device Description
Single Use Sterile Saline Breast Implant Sizer for Natrelle Style 68 Low Profile, 200cc
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MRD | Sizer, Mammary, Breast Implant Volume | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34178 | Invasive breast implant sizer, fixed, single-use | A device intended to be placed intraoperatively in a surgically-prepared mammary pocket to provide a volume measurement for the appropriate selection of a breast implant (mammary prosthesis). The device consists of a balloon-like elastomer shell that is either filled to an optimal volume via tubing and port, or is prefilled with a fixed amount of silicone gel, which is placed in the pocket and then removed. The sizer may vary in shape, profile, and volume. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M746SZLP682000 | HIBCC |
Customer Contacts
- Phone
- 888-878-0811
- [email protected]