Compression Stocking 403

GUDID G420403

Forearm Sleeve Wrist to Elbow

Gottfried Medical, Inc.

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• Primary Device ID: G420403
• NIH Device Record Key: 28dfefbe-2c7f-4037-a809-1a6521ec2835
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Compression Stocking
• Version Model Number: 403
• Catalog Number: 403
• Company DUNS: 038706180
• Company Name: Gottfried Medical, 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: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G420403 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K823737

FDA Product Code

• DWL: Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
• FQL: Stocking, Medical Support (For General Medical Purposes)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-23
• Device Publish Date: 2023-08-15

On-Brand Devices [Compression Stocking]

• G420475: Elbow to Axilla with Shoulder Flap
• G420474: Leg Band, Below Knee to Ankle
• G420473: Scrotum Support
• G420472: Arm Band, to 6"
• G420471: Thigh Band, to 12"
• G420470: Knee Band, to 8"
• G420461: Foot Glove, to Knee
• G420460: Foot Glove, to Ankle
• G420453: Finger Cover
• G420452: Mitten to Elbow
• G420451: Mitten to Wrist
• G420442: Two Arm Bolero
• G420441: One Arm Bolero
• G420432: Chin Strap
• G420431: Face Mask, Open
• G420430: Face Mask, Closed
• G420426: Head Band
• G420425: Foam Insert for Turtle Neck
• G420424: Neck Band
• G420422: Suit with Sleeves Two Legs Below Knee
• G420421: Suit with Sleeves One Leg Below Knee
• G420420: Suit with Sleeves
• G420418: Suit with Sleeves Above Knee
• G420417: Brief with Sleeves Open Crotch
• G420416: Brief with Sleeves, with Flap or Snaps
• G420415: Brief, Sleeveless with Snaps or Velcro
• G420414: Brief, Sleeveless with Flap
• G420413: Sternum Pressure Support
• G420412: Vest with Sleeves
• G420410: Vest, Sleeveless
• G420409: Arm Sleeve, Elbow to Axilla
• G420408: Anklet
• G420407: Glove through Shoulder Flap
• G420406: Arm Stump with Shoulder Flap
• G420405: Arm Sleeve Stump Closed
• G420404: Gauntlet to Elbow
• G420403: Forearm Sleeve Wrist to Elbow
• G420402: Glove to Elbow
• G420401: Glove to Wrist
• G420400: Glove to Axilla
• G420342: Stump Support, Chap Style to Below Knee
• G420341: Stump Support, Chap Style to Above Knee
• G420339: Waist 2 Stumps Closed Crotch
• G420338: Waist Two Stumps Open Crotch
• G420337: Waist One Leg/Stump Closed
• G420336: Waist One Leg/Stump Open
• G420335: Waist One Stump Panty Closed
• G420334: Waist One Stump Panty Open Crotch
• G420333: Waist One Stump Open Crotch
• G420332: Stump Support Below Knee