Spectrum, Inc. 725100

GUDID 10850301007799

Specimin Container, 32 Oz, Sterile

SPECTRUM, INC.

General specimen container IVD, no additive, sterile

• Primary Device ID: 10850301007799
• NIH Device Record Key: 22b1bda2-9e4b-4ef8-9b84-f06798e1c90e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spectrum, Inc.
• Version Model Number: 987-03923-000
• Catalog Number: 725100
• Company DUNS: 080458964
• Company Name: SPECTRUM, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(214)492-0506
• Email: hfahrlander@spectrumlabs.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850301007790 [Primary]
GS1	00850301007792 [Primary]
GS1	10850301007799 [Package]; Contains: 00850301007792; Package: Shipper [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K863872

FDA Product Code

• LPZ: Container, frozen donor tissue storage

Sterilization

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

[10850301007799]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-07-03
• Device Publish Date: 2017-07-21

On-Brand Devices [Spectrum, Inc.]

• 10855495007402: Non-Sterile Heel/Elbow Protection Cushion
• 10855495007386: Sterile Equipment Drape, Microlase, 5" X 59", latex Free
• 10855495007372: Non-sterile Equipment Drape, Disposable Sheath, Bulk
• 10855495007365: Sterile Equipment Drape, AssistArm Surgical Drape, 7" X 96", Latex Free
• 10855495007358: Sterile Equipment Drape, 12" X 100" w/Bag Clip, Latex Free
• 10855495007348: Sterile Equipment Drape, ESS Universal Camera Drape, 7" X 96", Latex Free
• 20855495007331: Sterile Equipment Drape, Josnoe Gama Probe Cover, 5" X 96", Latex Free
• 20855495007324: Sterile Equipment Drape, Tetra Mobile X-Ray Image Intensifier
• 10855495007310: 1 Ply Stockinette- 50/50% - 6" X 6 Yards - Sterile
• 10855495007303: 1 Ply Stockinette- 50/50% - 6" X 5 Yards - Sterile
• 10855495007297: 1 Ply Stockinette- 50/50% - 6" X 4 Yards - Sterile
• 10855495007280: 1 Ply Stockinette- 50/50% - 4" X 5 Yards - Sterile
• 10855495007273: 1 Ply Stockinette- 50/50% - 4" X 4 Yards - Sterile
• 10855495007266: 1 Ply Stockinette- 50/50% - 4" X 3 Yards - Sterile
• 10855495007259: 1 Ply Stockinette- 50/50% - 2" X 4 Yards - Sterile
• 10855495007242: Stockinette- 50/50% - Bias, 6" X 6 Yards - Sterile
• 10855495007235: Stockinette- 50/50% - Bias, 6" X 5 Yards - Sterile
• 10855495007228: Stockinette- 50/50% - Bias, 6" X 4 Yards - Sterile
• 10855495007211: Stockinette- 50/50% - Bias, 4" X 5 Yards - Sterile
• 10855495007204: Stockinette- 50/50% - Bias, 4" X 4 Yards - Sterile
• 10855495007198: Stockinette- 50/50% - Bias, 4" X 3 Yards - Sterile
• 10855495007181: Stockinette- 50/50% - Bias, 3" X 4 Yards - Sterile
• 10855495007174: Stockinette, Bulk, 50/50 Blend Tubular, 8" x 25 Yards, Non-sterile
• 10855495007167: Stockinette, Bulk, 50/50 Blend Tubular,6" x 25 Yards, Non-sterile
• 10855495007150: Stockinette, Bulk, 50/50 Blend Tubular, 4" x 25 Yards, Non-sterile
• 10855495007143: Stockinette, Bulk, 50/50 Blend Tubular, 3" x 25 Yards, Non-sterile
• 10855495007136: Stockinette, Bulk, 50/50 Blend Tubular, 2" x 25 Yards, Non-sterile
• 10855495007129: Hy'N Dry Stockinette, Impervious, 12" X 5' with straps, Sterile
• 10855495007112: Hy'N Dry Stockinette, Impervious, 10" X 4', with straps, Sterile
• 10855495007105: Hy'N Dry Stockinette, Impervious, 8"X 4' with straps, Sterile
• 10855495007099: Hy'N Dry Stockinette, Impervious, Hips/Legs Large, Sterile
• 10855495007082: Hy'N Dry Stockinette, Impervious, Hips/Legs Regular, Sterile
• 10855495007075: Hy'N Dry Stockinette, Impervious,Arms/Legs, Small, Sterile
• 10855495007068: 2 Ply Stockinette, 50/50, 8" X 5', Sterile
• 10855495007051: 2 Ply Stockinette, 50/50, 8" X 6', Sterile
• 10855495007044: 2 Ply Stockinette, 50/50, 6" X 6', Sterile
• 10855495007037: 2 Ply Stockinette, 50/50, 6" X 5', Sterile
• 10855495007020: 2 Ply Stockinette, 50/50 ,6" X 4.5', Sterile
• 10855495007013: 2 Ply Stockinette, 50/50, 6" X 4', Sterile
• 10855495007006: 2 Ply Stockinette, 50/50, 6" X 3', Sterile
• 10850301007997: 2 Ply Stockinette, 50/50, 4" X 6', Sterile
• 10850301007980: 2 Ply Stockinette, 50/50, 4" X5', Sterile
• 10850301007966: 2 Ply Stockinette, 50/50, 4" x 3', Sterile
• 10850301007959: 2 Ply Stockinette, 50/50, 3" X 4', Sterile
• 10850301007942: 2 Ply Stockinette, 50/50, 3" X 3', Sterile
• 10850301007935: 2 Ply Stockinette, 50/50, 2" X 4', Sterile
• 10850301007928: Strap-Stroll Stockinette, 8" X 6', Sterile
• 10850301007911: Strap-Stroll Stockinette, 8" X 5', Sterile
• 10850301007904: Strap-Stroll Stockinette, 6" X 6', Sterile
• 10850301007898: Strap-Stroll Stockinette, 6" X 5', Sterile