OR Specific

GUDID 10841027102967

Drape, Heavy Duty, For 5' Big Case Back Table Model 428 Series. Case of 10. Sterile.- Each

PEDIGO PRODUCTS, INC.

Patient surgical drape, single-use

• Primary Device ID: 10841027102967
• NIH Device Record Key: 6785119e-f759-48c0-b8a3-d221ba40bd05
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OR Specific
• Version Model Number: 419-HD-S
• Company DUNS: 008301772
• Company Name: PEDIGO PRODUCTS, 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841027102960 [Primary]
GS1	10841027102967 [Package]; Contains: 00841027102960; Package: CASE [10 Units]; In Commercial Distribution

FDA Product Code

• PUI: Drape, Surgical, Exempt

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-16
• Device Publish Date: 2025-12-08

Devices Manufactured by PEDIGO PRODUCTS, INC.

• 00841027101604 - Pedigo Products, Inc.: 2025-12-16 DC250L, 120V, CSWRH W/LK, WITH CASTERS, ENTHERMICS
• 00841027102298 - Pedigo Products, Inc.: 2025-12-16 IVNOW, EQUIPOTENTIAL, TYPE-J, 2 POD
• 00841027102311 - Pedigo Products, Inc.: 2025-12-16 IVNOW, EQUIPOTENTIAL, TYPE-N, 2 POD
• 00841027102328 - Pedigo Products, Inc.: 2025-12-16 IVNOW, STANDARD, TYPE-B, 2 POD, MEDLINE
• 00841027102335 - Pedigo Products, Inc.: 2025-12-16 IVNOW, STANDARD, TYPE-B, 3 POD
• 00841027102342 - Pedigo Products, Inc.: 2025-12-16 IVNOW, EQUIPOTENTIAL, TYPE-B, 3 POD
• 00841027102359 - Pedigo Products, Inc.: 2025-12-16 IVNOW, EQUIPOTENTIAL, TYPE-D/M, 3 POD
• 00841027102366 - Pedigo Products, Inc.: 2025-12-16 IVNOW, EQUIPOTENTIAL, TYPE-E/F, 3 POD