Primary Device ID | 00810057380334 |
NIH Device Record Key | bc3826a7-b133-4ef8-8d30-ae6f6c3b00a9 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | OrthoWrap |
Version Model Number | 50mm x 70mm x 0.05mm |
Catalog Number | 47501-01 |
Company DUNS | 188582360 |
Company Name | MAST BIOSURGERY USA INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 866-627-8246 |
CustomerService@mastbio.com | |
Phone | 866-627-8246 |
CustomerService@mastbio.com | |
Phone | 866-627-8246 |
CustomerService@mastbio.com | |
Phone | 866-627-8246 |
CustomerService@mastbio.com | |
Phone | 866-627-8246 |
CustomerService@mastbio.com | |
Phone | 866-627-8246 |
CustomerService@mastbio.com | |
Phone | 866-627-8246 |
CustomerService@mastbio.com |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00810057380334 [Package] Contains: 00810057380402 Package: 5 unit box [5 Units] In Commercial Distribution |
GS1 | 00810057380402 [Primary] |
FTL | Mesh, Surgical, Polymeric |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2022-06-10 |
Device Publish Date | 2020-11-10 |
00810057380334 | Bioresorbable protective sheet made from polylactide: a copolymer of 70:30 Poly(L-lactide-co-D,L |
00810057380389 | Bioresorbable protective sheet made from polylactide: a copolymer of 70:30 Poly(L-lactide-co-D,L |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ORTHOWRAP 77222458 3442044 Live/Registered |
MAST Biosurgry AG 2007-07-05 |