Greenwald Surgical Company, Inc P66D

GUDID 10801334000257

Smith Endoscopic Handle

GRACE MANUFACTURING, INC.

Electrosurgical handpiece, reusable

• Primary Device ID: 10801334000257
• NIH Device Record Key: 5b760f80-cb58-4169-bdd1-211d52eb7408
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Greenwald Surgical Company, Inc
• Version Model Number: 22549-00
• Catalog Number: P66D
• Company DUNS: 607903382
• Company Name: GRACE MANUFACTURING, INC.
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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
GS1	10801334000257 [Primary]

FDA Product Code

• HGI: Electrocautery, Gynecologic (And Accessories)

Sterilization

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

[10801334000257]

Liquid Chemical;Ethylene Oxide;Moist Heat or Steam Sterilization

[10801334000257]

Liquid Chemical;Ethylene Oxide;Moist Heat or Steam Sterilization

[10801334000257]

Liquid Chemical;Ethylene Oxide;Moist Heat or Steam Sterilization

[10801334000257]

Liquid Chemical;Ethylene Oxide;Moist Heat or Steam Sterilization

[10801334000257]

Liquid Chemical;Ethylene Oxide;Moist Heat or Steam Sterilization

[10801334000257]

Liquid Chemical;Ethylene Oxide;Moist Heat or Steam Sterilization

[10801334000257]

Liquid Chemical;Ethylene Oxide;Moist Heat or Steam Sterilization

[10801334000257]

Liquid Chemical;Ethylene Oxide;Moist Heat or Steam Sterilization

[10801334000257]

Liquid Chemical;Ethylene Oxide;Moist Heat or Steam Sterilization

[10801334000257]

Liquid Chemical;Ethylene Oxide;Moist Heat or Steam Sterilization

[10801334000257]

Liquid Chemical;Ethylene Oxide;Moist Heat or Steam Sterilization

[10801334000257]

Liquid Chemical;Ethylene Oxide;Moist Heat or Steam Sterilization

[10801334000257]

Liquid Chemical;Ethylene Oxide;Moist Heat or Steam Sterilization

[10801334000257]

Liquid Chemical;Ethylene Oxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2023-04-04
• Device Publish Date: 2016-09-23

Devices Manufactured by GRACE MANUFACTURING, INC.

• 10801334000158 - Greenwald Surgical Company, Inc.: 2023-07-25 Whitver Meatus Clamp
• 10801334000165 - Greenwald Surgical Company, Inc.: 2023-07-25 Zipser Meatus Clamp
• 10801334000363 - Greenwald Surgical Company, Inc.: 2023-07-25 Hyams Meatus Clamp
• 10801334001469 - Greenwald Surgical Company, Inc.: 2023-07-25 Stamey Needle, Straight tip
• 10801334001476 - Greenwald Surgical Company, Inc.: 2023-07-25 Stamey Needle, 15 degree angled tip
• 10801334001483 - Greenwald Surgical Company, Inc.: 2023-07-25 Stamey Needle, 30 degree angled tip
• 10801334000257 - Greenwald Surgical Company, Inc: 2023-04-04Smith Endoscopic Handle
• 10801334000257 - Greenwald Surgical Company, Inc: 2023-04-04 Smith Endoscopic Handle
• 10801334004804 - Greenwald Surgical Company, Inc.: 2022-03-29 Flexible Endoscopic Electrode, Bugbee Tip