Spectrum, Inc. 956925TET

GUDID 20855495007324

Sterile Equipment Drape, Tetra Mobile X-Ray Image Intensifier

SPECTRUM, INC.

Instrument/equipment drape, single-use, sterile
Primary Device ID20855495007324
NIH Device Record Keya729fdcf-6df9-482e-a73c-80fbef2a0f8a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpectrum, Inc.
Version Model Number982-03725-000
Catalog Number956925TET
Company DUNS080458964
Company NameSPECTRUM, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(214)492-0506
Emailhfahrlander@spectrumlabs.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100855495007320 [Primary]
GS110855495007327 [Package]
Contains: 00855495007320
Package: Box [10 Units]
In Commercial Distribution
GS120855495007324 [Package]
Contains: 10855495007327
Package: Shipper [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPZContainer, frozen donor tissue storage

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[20855495007324]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-07-21

On-Brand Devices [Spectrum, Inc.]

10855495007402Non-Sterile Heel/Elbow Protection Cushion
10855495007386Sterile Equipment Drape, Microlase, 5" X 59", latex Free
10855495007372Non-sterile Equipment Drape, Disposable Sheath, Bulk
10855495007365Sterile Equipment Drape, AssistArm Surgical Drape, 7" X 96", Latex Free
10855495007358Sterile Equipment Drape, 12" X 100" w/Bag Clip, Latex Free
10855495007348Sterile Equipment Drape, ESS Universal Camera Drape, 7" X 96", Latex Free
20855495007331Sterile Equipment Drape, Josnoe Gama Probe Cover, 5" X 96", Latex Free
20855495007324Sterile Equipment Drape, Tetra Mobile X-Ray Image Intensifier
108554950073101 Ply Stockinette- 50/50% - 6" X 6 Yards - Sterile
108554950073031 Ply Stockinette- 50/50% - 6" X 5 Yards - Sterile
108554950072971 Ply Stockinette- 50/50% - 6" X 4 Yards - Sterile
108554950072801 Ply Stockinette- 50/50% - 4" X 5 Yards - Sterile
108554950072731 Ply Stockinette- 50/50% - 4" X 4 Yards - Sterile
108554950072661 Ply Stockinette- 50/50% - 4" X 3 Yards - Sterile
108554950072591 Ply Stockinette- 50/50% - 2" X 4 Yards - Sterile
10855495007242Stockinette- 50/50% - Bias, 6" X 6 Yards - Sterile
10855495007235Stockinette- 50/50% - Bias, 6" X 5 Yards - Sterile
10855495007228Stockinette- 50/50% - Bias, 6" X 4 Yards - Sterile
10855495007211Stockinette- 50/50% - Bias, 4" X 5 Yards - Sterile
10855495007204Stockinette- 50/50% - Bias, 4" X 4 Yards - Sterile
10855495007198Stockinette- 50/50% - Bias, 4" X 3 Yards - Sterile
10855495007181Stockinette- 50/50% - Bias, 3" X 4 Yards - Sterile
10855495007174Stockinette, Bulk, 50/50 Blend Tubular, 8" x 25 Yards, Non-sterile
10855495007167Stockinette, Bulk, 50/50 Blend Tubular,6" x 25 Yards, Non-sterile
10855495007150Stockinette, Bulk, 50/50 Blend Tubular, 4" x 25 Yards, Non-sterile
10855495007143Stockinette, Bulk, 50/50 Blend Tubular, 3" x 25 Yards, Non-sterile
10855495007136Stockinette, Bulk, 50/50 Blend Tubular, 2" x 25 Yards, Non-sterile
10855495007129Hy'N Dry Stockinette, Impervious, 12" X 5' with straps, Sterile
10855495007112Hy'N Dry Stockinette, Impervious, 10" X 4', with straps, Sterile
10855495007105Hy'N Dry Stockinette, Impervious, 8"X 4' with straps, Sterile
10855495007099Hy'N Dry Stockinette, Impervious, Hips/Legs Large, Sterile
10855495007082Hy'N Dry Stockinette, Impervious, Hips/Legs Regular, Sterile
10855495007075Hy'N Dry Stockinette, Impervious,Arms/Legs, Small, Sterile
108554950070682 Ply Stockinette, 50/50, 8" X 5', Sterile
108554950070512 Ply Stockinette, 50/50, 8" X 6', Sterile
108554950070442 Ply Stockinette, 50/50, 6" X 6', Sterile
108554950070372 Ply Stockinette, 50/50, 6" X 5', Sterile
108554950070202 Ply Stockinette, 50/50 ,6" X 4.5', Sterile
108554950070132 Ply Stockinette, 50/50, 6" X 4', Sterile
108554950070062 Ply Stockinette, 50/50, 6" X 3', Sterile
108503010079972 Ply Stockinette, 50/50, 4" X 6', Sterile
108503010079802 Ply Stockinette, 50/50, 4" X5', Sterile
108503010079662 Ply Stockinette, 50/50, 4" x 3', Sterile
108503010079592 Ply Stockinette, 50/50, 3" X 4', Sterile
108503010079422 Ply Stockinette, 50/50, 3" X 3', Sterile
108503010079352 Ply Stockinette, 50/50, 2" X 4', Sterile
10850301007928Strap-Stroll Stockinette, 8" X 6', Sterile
10850301007911Strap-Stroll Stockinette, 8" X 5', Sterile
10850301007904Strap-Stroll Stockinette, 6" X 6', Sterile
10850301007898Strap-Stroll Stockinette, 6" X 5', Sterile

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