BandLoc 01-1500-0035

GUDID 00841132128817

DEPTH GAUGE 10-100MM

ORTHOPEDIATRICS CORP.

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 00841132128817
• NIH Device Record Key: 39bfe6d3-370a-4055-8a38-e5efe06b2a56
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BandLoc
• Version Model Number: 01-1500-0035
• Catalog Number: 01-1500-0035
• Company DUNS: 796416191
• Company Name: ORTHOPEDIATRICS CORP.
• 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

Customer Support Contacts

• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841132128817 [Primary]

FDA Product Code

• HTJ: GAUGE, DEPTH

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-10-31

On-Brand Devices [BandLoc]

• 00841132137956: BANDLOC MINI LRG SET SCREW CADDY LID
• 00841132137161: BANDLOC CASE LID
• 00841132136003: BANDLOC CASE LID
• 00841132135990: LARGE SET SCREW CADDY
• 00841132135914: BANDLOC STERILE IMPLANT
• 00841132128817: DEPTH GAUGE 10-100MM
• 00841132128800: OrthoPediatrics BandLoc Case Caddy Lid
• 00841132124413: BandLoc 5.5/6.0 Sterile Implant
• 00841132144039: BANDLOC IMPLANT & INSTRUMENT
• 00841132138427: BANDLOC MINI LID