FDA.report

SCOTT'S HIGHSPEED HP SLEEVE 1" x 8" 500/bx

Primary DI
D77810750140
Brand
SCOTT'S HIGHSPEED HP SLEEVE 1" x 8" 500/bx
Company
SCOTT'S DENTAL SUPPLY L.L.C.
Model
107-5014
Catalog number
107-5014
Device description
HANDPIECE SLEEVE (500/box) Dimensions: 1" x 8", Color: Clear; For more information: https://www.scottsdental.com/catalog/product/view/id/24006/s/handpiece-sleeves-scott-s-select/
Published
2021-02-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
PEMDental barriers and sleeves

Product Code Classifications

CodeDeviceSpecialtyClass
PEMDental Barriers And SleevesGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D77810750141PrimaryHIBCC0
D77810750140Unit of UseHIBCC0

GMDN Terms

TermDefinition
Medical equipment drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)901-3368info@scottsdental.com

Regulatory Flags

DUNS number
137217043
Device count
500
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
D77810701992Scott's Select Cotton Rolls107-0199107-01992024-08-27
D77810702990Scott's Select Non-Woven Sponges 2 x 2 107-0299107-02992024-08-27
D77810704440Scott's Select Non-Woven Sponges 4 x 4107-0444107-04442024-08-27
D77810750500Scott's Select Patient Bibs107-5050107-50502024-08-27
D77810750540Scott's Select Patient Bibs107-5054107-50542024-08-27
D77810750560Scott's Select Patient Bibs107-5056107-50562024-08-27
D77810750580Scott's Select Patient Bibs107-5058107-50582024-08-27
D77819950610Scott's Select ColorFil Flow Single-Shade Prismatic199-5061199-50612024-08-27
D77819950630Scott's Select ColorFil Flow Blocker199-5063199-50632024-08-27
D77819950500Scott's Select ColorFil Single-Shade Prismatic199-5050199-50502024-08-26
D77819950530Scott's Select ColorFil Blocker199-5053199-50532024-08-26
D77819950570Scott's Select ColorFil Single-Shade Prismatic199-5057199-50572024-08-26
D77819950590Scott's Select ColorFil Blocker199-5059199-50592024-08-26
D77835054990Scott's Select Nitrile Gloves350-5499350-54992024-08-22
D77835055000Scott's Select Nitrile Gloves350-5500350-55002024-08-22
D77835055050Scott's Select Nitrile Gloves350-5505350-55052024-08-22
D77835055110Scott's Select Nitrile Gloves350-5511350-55112024-08-22
D77835086300Scott's Select Latex Gloves350-8630350-86302024-08-22
D77835086320Scott's Select Latex Gloves350-3632350-36322024-08-22
D77835086340Scott's Select Latex Gloves350-8634350-86342024-08-22

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