Coulmed - PAD INSERT W/LEG FLAP FOR BANANA BOOT STIRRUPS, PRESSURE RELIEF MEMORY FOAM, BLACK, SOFTSKIN COVERING
2023-01-06
COULMED PRODUCTS GROUP LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3015625160 | 3015625160 | COULMED PRODUCTS GROUP LLC | 1 | N | 2026-01-01 | 44 Commerce Street Springfield NJ US 07081 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 274159 | 1200455516 | K101689 | EMM EQUIPMENT COVER-POLYTHYLENE | KKX | 2010-09-20 |
| 274159 | 1015312191 | ||||
| 274159 | 1110261739 | ||||
| 274159 | 1169179804 | ||||
| 274159 | 1272993076 | ||||
| 274159 | 1291476935 | ||||
| 274159 | 1452072738 | ||||
| 274159 | 1587739128 | ||||
| 274159 | 2032892134 | ||||
| 274159 | 2042901536 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| KKX | 1 | 2010-09-20 |
GUDID#
Coulmed - Replacement Clamshell Boot Pads for Allen Junior PAL Surgical Stirrups. Tier II Pressure Relief Memory Foam with Black Skin-Soft Conductive Covering. 2 Piece Set (Left & Right).
2023-01-06
Coulmed - Replacement FootHugger Boot Pads for Allen PAL Pro, PAL, and SAM III Surgical Stirrups.
2023-01-06
Coulmed - Replacement Boot Pads for Yellofins & Yellofins Elite Stirrups. Tier II Pressure Relief Memory Foam with Black Skin-Soft Conductive Covering. 2 Piece Set (right & left).
2023-01-06
Coulmed - Replacement Left Boot Pad for Yellofins & Yellofins Elite Stirrups. Tier II Pressure Relief Memory Foam with Black Skin-Soft Conductive Covering.
2023-01-06
Coulmed - Replacement Right Boot Pad for Yellofins & Yellofins Elite Stirrups. Tier II Pressure Relief Memory Foam with Black Skin-Soft Conductive Covering.
2023-01-06
Coulmed - Replacement Pads for Ultrafin Surgical Stirrups. 2 Piece Set (Left & Right), Tier II Pressure Relief Pads with Black Skin-Soft Conductive Covering.
2023-01-06
Coulmed - "Sterile Mini C-Arm Cover fitted for OEC Mini 6600/6800 C-Arms: 48"" x 84"""
2023-01-06
Coulmed - Covex Sterile Mini C-Arm Cover fitted for OrthoScan C-Arm, Keyboard, and Monitor Handles
2023-01-06
Coulmed - "Foot Switch Cover, Disposable, 17"" X 15"""
2023-01-06
Coulmed - "Covex Sterile C-Arm Cover fitted for Fluoroscan Mini C-Arm, With Elastic Opening, 54"" x 78"""
2023-01-06
Coulmed - "Covex Sterile C-Arm Cover: Half Bag with Latex-Free Band, 36""W x 80""L"
2023-01-06
Coulmed - "Covex Sterile Dome Cover: 27"" Polyethylene Bag with Elastic Band"
2023-01-06
Coulmed - "Covex Sterile C-Arm Cover: 41"" x 74"""
2023-01-06
Coulmed - "Covex Sterile C-Arm Drape with Elastic Bands: 41"" x 74"""
2023-01-06
Coulmed - "Covex Sterile C-Arm Drape with Tape/Bands: 41"" x 74"""
2023-01-06
Coulmed - "Covex Sterile C-Arm Cover Kit fitted for OEC Elite, 9900, 9800, 9600, and Brivo C-Arm's. Includes C-Arm Drape, 12"" II, X-Ray Tube, and Footswitch Cover"
2023-01-06
Coulmed - "Covex Sterile X-Ray Cassette Cover: 24"" x 24"""
2023-01-06
Coulmed - "Covex Sterile Microscope Drape for Zeiss MD: 46"" x 105"""
2023-01-06
Coulmed - "Covex Sterile Microscope Drape for Zeiss MD: 54"" x 150"""
2023-01-06
Coulmed - "Covex Sterile Microscope Drape for Zeiss MD: 46"" x 120"" (117cm x 305cm)"
2023-01-06
Coulmed - "Covex Sterile Microscope Drape for Leica: 46"" x 120"""
2023-01-06
Coulmed - "Covex Sterile Microscope Drape for Leica: 54"" x 120"" (137cm x 305cm)"
2023-01-06
Coulmed - "Covex Sterile Microscope Drape for Leica: 54"" x 150"" (137cm x 381cm)"
2023-01-06
Coulmed - "Covex Sterile Probe Cover with Gel: 5"" x 96"" inch"
2023-01-06
Coulmed - "Covex Sterile Camera Drape with Blue Elasticized Tip: 7"" x 96"""
2023-01-06
Coulmed - "Covex Heavy Duty Sterile Drape for Two Tier Back Table: One Piece Construction, 49""Long"
2023-01-06
Coulmed - "Covex Heavy Duty Sterile Drape for Two Tier Back Table: One Piece Construction, 60""Long"
2023-01-06
Coulmed - "60"" Wide Custom Double Back Table Cover"
2023-01-06
Coulmed - "Covex Heavy Duty Sterile Drape for Two Tier Back Table: One Piece Construction, 72""Long"
2023-01-06
Coulmed - "Covex Custom Sterile Drape for Two Tier Tables with 8"" Back, One Piece Construction, 72""Long"
2023-01-06
Coulmed - Covex Heavy Duty Sterile Drape for OR Specific Two Tier Back Table: One Piece Construction, 4' Long
2023-01-06
Coulmed - Covex Heavy Duty Sterile Drape for OR Specific Two Tier Back Table: One Piece Construction, 5' Long
2023-01-06
Coulmed - Covex Heavy Duty Sterile Drape for OR Specific Two Tier Back Table: One Piece Construction, 6' Long
2023-01-06
Coulmed - "Sterile 3/4 Drape/Sheet: 57"" x 63"""
2023-01-06
Coulmed - "Universal Sterile Mayo Stand Drape/Cover: 23"" x 54"""
2023-01-06
Coulmed - "Mayo Stand Cover, 21"" X 18-1/2"" X 5/8"""
2023-01-06
Coulmed - Sterile Mini C-Arm Cover fitted for OEC Mini 6600/6800 C-Arms: 48" x 84"
2023-01-06
Coulmed - Covex Sterile Mini C-Arm Cover fitted for OrthoScan C-Arm, Keyboard, and Monitor Handles
2023-01-06
Coulmed - Foot Switch Cover, Disposable, 17" X 15"
2023-01-06