SparrowHawk

GUDID 00817428020394

5040 SparrowHawk Endomyocardial Biopsy Forceps, 1.8mm X 50cm, Max-Curve, Disposable

ATC TECHNOLOGIES, INC.

Endomyocardial biopsy forceps, single-use Endomyocardial biopsy forceps, single-use Endomyocardial biopsy forceps, single-use

• Primary Device ID: 00817428020394
• NIH Device Record Key: 61e304ed-63e3-4840-a511-2552697fd54e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SparrowHawk
• Version Model Number: 5040
• Company DUNS: 023131605
• Company Name: ATC TECHNOLOGIES, 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817428020387 [Primary]
GS1	00817428020394 [Package]; Contains: 00817428020387; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010473

FDA Product Code

• DWZ: Device, Biopsy, Endomyocardial

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [SparrowHawk]

• 00817428020615: 5058 SparrowHawk Endomyocardial Biopsy Forceps, 1.8mm X 105cm, Straight, Disposable
• 00817428020592: 5057 SparrowHawk Endomyocardial Biopsy Forceps, 1.8mm X 50cm, Soft-Curve, Disposable
• 00817428020578: 5055 SparrowHawk Endomyocardial Biopsy Forceps, 1.5mm X 105cm, Straight, Disposable
• 00817428020554: 5050 SparrowHawk Endomyocardial Biopsy Forceps, 1.5mm X 50cm, Straight, Disposable
• 00817428020530: 5049 SparrowHawk Endomyocardial Biopsy Forceps, 1.8mm X 105cm, Straight, Disposable
• 00817428020516: 5048 SparrowHawk Endomyocardial Biopsy Forceps, 1.8mm X 105cm, Straight, Disposable
• 00817428020493: 5047 SparrowHawk Endomyocardial Biopsy Forceps, 1.8mm X 105cm, Soft-Curve, Disposable
• 00817428020479: 5046 SparrowHawk Endomyocardial Biopsy Forceps, 1.8mm X 105cm, Straight, Disposable
• 00817428020455: 5044 SparrowHawk Endomyocardial Biopsy Forceps, 1.8mm X 50cm, Straight, Disposable
• 00817428020431: 5042 SparrowHawk Endomyocardial Biopsy Forceps, 1.8mm X 50cm, Pre-Curve, Disposable
• 00817428020417: 5041 SparrowHawk Endomyocardial Biopsy Forceps, 1.8mm X 50cm, Max-Curve, Disposable
• 00817428020394: 5040 SparrowHawk Endomyocardial Biopsy Forceps, 1.8mm X 50cm, Max-Curve, Disposable
• 00817428020370: 5039 SparrowHawk Endomyocardial Biopsy Forceps, 2.2mm X 105cm, Straight, Disposable
• 00817428020356: 5038 SparrowHawk Endomyocardial Biopsy Forceps, 2.2mm X 105cm, Straight, Disposable
• 00817428020325: 5037 SparrowHawk Endomyocardial Biopsy Forceps, 2.2mm X 105cm, Straight, Disposable
• 00817428020318: 5036 SparrowHawk Endomyocardial Biopsy Forceps, 2.2mm X 105cm, Straight, Disposable
• 00817428020295: 5035 SparrowHawk Endomyocardial Biopsy Forceps, 2.2mm X 50cm, Straight, Disposable
• 00817428020271: 5034 SparrowHawk Endomyocardial Biopsy Forceps, 2.2mm X 50cm, Pre-Curve, Disposable
• 00817428020257: 5033 SparrowHawk Endomyocardial Biopsy Forceps, 2.2mm X 50cm, Pre-Curve, Disposable
• 00817428020233: 5032 SparrowHawk Endomyocardial Biopsy Forceps, 2.2mm X 105cm, Straight, Disposable
• 00817428020219: 5031 SparrowHawk Endomyocardial Biopsy Forceps, 2.2mm X 50cm, Max-Curve, Disposable
• 00817428020196: 5030 SparrowHawk Endomyocardial Biopsy Forceps, 2.2mm X 50cm, Max-Curve, Disposable