FDA.report

CVS Health

Primary DI
20050428415201
Brand
CVS Health
Company
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Model
400570CV1
Device description
Finger Splint
Published
2022-04-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
ILHSplint, Hand, And Components

Product Code Classifications

CodeDeviceSpecialtyClass
ILHSplint, Hand, And ComponentsPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10050428415204PackageGS124In Commercial Distribution
20050428415201PackageGS16In Commercial Distribution
00050428415207PrimaryGS10
40050428415205Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1005042841520410050428415204
2005042841520120050428415201
00050428415207000504284152070504284152070050428415207
4005042841520540050428415205

GMDN Terms

TermDefinition
Hand/finger splint, single-useA rigid or semi-rigid device intended to immobilize an injured/diseased hand and/or finger to support, align or prevent injury during the healing process. It is applied externally to the hand/finger/wrist and typically held in place with self-retaining fasteners (e.g., Velcro bands) or bandage wraps. This is a single-patient device that may be reapplied over a short term (single-use) before being discarded.

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-746-7287CustomerService@Caremark.com

Regulatory Flags

DUNS number
062312574
Device count
2
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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

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00050428005422CVS 837160WF232026-02-13
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00050428005583CVS 689466LB152026-01-28
10050428005603CVS 689509LB262026-01-26
10050428005610CVS 689573LB462026-01-23
10050428273484CVS Health TamponsBCVGC32(L/R)2025-12-31
00050428005842CVS 695535BM332025-12-11
00050428005804CVS 275172BF7222025-12-10
00050428005897CVS 695560XL cuff2025-12-10
10050428005832CVS 695534BM222025-12-09
10050428005856CVS 695537BM432025-12-09
10842942017541CVS4608662025-12-08

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