Primary Device ID | G0648317270027830 |
NIH Device Record Key | da298920-3bbc-41a1-b6a1-fe187354400b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | GAITKEEPER Cast Shoe |
Version Model Number | 831727002783 |
Company DUNS | 116685742 |
Company Name | Walgreen Health Solutions, LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | true |
Device Issuing Agency | Device ID |
---|---|
HIBCC | G0648317270027830 [Primary] |
IPG | Shoe, Cast |
KNP | Orthosis, Corrective Shoe |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-06-26 |
Device Publish Date | 2023-06-16 |
G0648317270027900 | Ankle High Square Toe Shoe - X-Large |
G0648317270027830 | Ankle High Square Toe Shoe - Large |
G0648317270027760 | Ankle High Square Toe Shoe - Medium |
G0648317270027690 | Ankle High Square Toe Shoe - Small |
G0648317270027520 | High Square Toe Shoe X-Small |
G0648317270026600 | GAITKEEPER® Round Toe Cast Shoe - X-Large |
G0648317270022950 | GAITKEEPER® Round Toe Cast Shoe - Large |
G0648317270022880 | GAITKEEPER® Round Toe Cast Shoe - Medium |
G0648317270022710 | GAITKEEPER® Round Toe Cast Shoe - Small |
G0648317270022640 | GAITKEEPER® Round Toe Cast Shoe - XSmall |