Strauss Surgical

GUDID 00851925007700

AMERICAN MEDICAL ENDOSCOPY, INC.

Fibreoptic light cable

• Primary Device ID: 00851925007700
• NIH Device Record Key: b0165f16-be86-4c76-b2c1-7580aa70dfc5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Strauss Surgical
• Version Model Number: STS-LC-KD-10CLR
• Company DUNS: 024725124
• Company Name: AMERICAN MEDICAL ENDOSCOPY, 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851925007700 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021931

FDA Product Code

• HBI: Illuminator, Fiberoptic, Surgical Field

Sterilization

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

[00851925007700]

Moist Heat or Steam Sterilization;Ultraviolet Light

[00851925007700]

Moist Heat or Steam Sterilization;Ultraviolet Light

[00851925007700]

Moist Heat or Steam Sterilization;Ultraviolet Light

[00851925007700]

Moist Heat or Steam Sterilization;Ultraviolet Light

[00851925007700]

Moist Heat or Steam Sterilization;Ultraviolet Light

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-26
• Device Publish Date: 2022-05-18

On-Brand Devices [Strauss Surgical]

• 00851925007069: STS-1040-175AA
• 00851925007052: STS-3050-312BA
• 00851925007045: STS-3050-312AA
• 00851925007038: STS-3100-344BA
• 00851925007021: STS-3100-344FA
• 00851925007014: STS-3100-344AA
• 00851925007403: STS-4080-164CA
• 00851925007380: STS-ACC-6000-MEMD
• 00851925007359: STS-ACC-5000-CAPD-000
• 00851925007342: STS-ACC-5043-100N-BRU
• 00851925007335: STS-ACC-5030-100N-BRU
• 00851925007328: STS-ACC-5030-470N-BRU
• 00851925007311: STS-ACC-5063-470N-BRU
• 00851925007304: STS-URO-5000-BRGA-002
• 00851925007397: STS-2040-283BA-OLY
• 00851925007373: STS-2029-302AA
• 00851925007366: STS-7027-110ASA
• 00851925007298: STS-5135-320HA
• 00851925007281: STS-5135-220HA
• 00851925007274: STS-5190-220HA
• 00851925007250: STS-6060-310HA
• 00851925007243: STS-6075-310HA
• 00851925007236: STS-ACC-6000-BRGA-002
• 00851925007212: STS-6060-425HA
• 00851925007205: STS-6075-425HA
• 00851925007199: STS-4032-300N
• 00851925007182: STS-4038-300N
• 00851925007175: STS-2029-302BA
• 00851925007168: STS-2040-302CA
• 00851925007151: STS-2040-302BA
• 00851925007144: STS-2040-302AA
• 00851925007120: STS-7027-110-BSA
• 00851925007113: STS-1020-110BA
• 00851925007106: STS-1027-187BSA
• 00851925007090: STS-1040-175FA
• 00851925007083: STS-1040-175CA
• 00851925007076: STS-1040-175BA
• 00850024135710: STS-ART-P35ML
• 00850024135703: STS-ART-PROBE-K
• 00850024135697: STS-ART-PHP
• 00850024135437: STS-ART-400-170SP
• 00850024135420: STS-ART-030-170NN
• 00850024135413: STS-LAP-920-02
• 00850024135406: STS-LAP-430-93
• 00850024135390: STS-LAP-429-93
• 00850024135383: STS-LAP-220-53
• 00850024135376: STS-LAP-400-93
• 00850024135369: STS-LAP-020
• 00850024135352: STS-LAP-010-54
• 00850024135345: STS-LAP-010-53