FDA.report

Dr. Don's Lateral Arm Traction Sleeve

Primary DI
10840113230720
Brand
Dr. Don's Lateral Arm Traction Sleeve
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
711504
Device description
Intended to support and maintain the position of an anesthetized patient during surgery
Published
2021-03-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
CCXSUPPORT, PATIENT POSITION

Product Code Classifications

CodeDeviceSpecialtyClass
CCXSupport, Patient PositionAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10840113230720PackageGS110In Commercial Distribution
00840113230723PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084011323072010840113230720
00840113230723008401132307238401132307230840113230723

GMDN Terms

TermDefinition
Arm procedure positioner, single-useA device designed to support and stabilize a patient's arm in a desired position during a medical procedure [e.g., to maintain the patency of an intravenous (IV) needle or an intravascular catheter]. Also known as an arm posturing device or armboard, it is typically constructed as an elongated, curved, cushioned surface, and may be attached or fixed (e.g., onto a side rail). This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(616)698-7100customerservice@aspensurgical.com

Regulatory Flags

DUNS number
027680821
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
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
00814707023817Protek1-519-1028B2026-02-16
00840113231867Bard-ParkerST-1002026-02-15
00887482023389Symmetry53-16622026-02-15
00887482023396Symmetry53-16632026-02-15
00887482023402Symmetry53-16642026-02-15
00887482138373Sterion10-00-752026-02-15
00887482156186Symmetry53-1662T2026-02-15
00887482156223Symmetry53-1664T2026-02-15
20887482023376Symmetry53-16612026-02-15
10607151000100BOVIE001000102016-10-10
10607151000117BOVIE001100112016-10-10
10607151000124BOVIE001200122016-10-10
10607151001428BOVIEA1204PA1204P2016-10-12
10607151001534BovieA802EUA802EU2016-10-19
10607151001541BOVIEA1252CA1252C2016-10-12
10607151001589BovieA1255AA1255A2016-09-28
10607151002258BovieNLOTNLOT2017-02-10
10607151002579BOVIEA1254CA1254C2016-10-12
10607151004733BOVIEA1202A12022016-10-12
10607151004801BovieFSSEPFSSEP2016-09-16

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
05060624123696CS Align Pro Support - Replacement PadsCARE SURGICAL LIMITEDCCX2026-03-23
05060624126970CS Align Pro SupportCARE SURGICAL LIMITEDCCX2026-03-23
00850055249066Prime Medical LLCPrime Medical LLCCCX2026-03-05
00850055249134Prime Medical LLCPrime Medical LLCCCX2026-03-05
00850055249141Prime Medical LLCPrime Medical LLCCCX2026-03-05
00850055249165Prime Medical LLCPrime Medical LLCCCX2026-03-05
00850055249172Prime Medical LLCPrime Medical LLCCCX2026-03-05
00850055249189Prime Medical LLCPrime Medical LLCCCX2026-03-05
00850055249196Prime Medical LLCPrime Medical LLCCCX2026-03-05
00850055249202Prime Medical LLCPrime Medical LLCCCX2026-03-05
00850055249219Prime Medical LLCPrime Medical LLCCCX2026-03-05
00850055249318Prime Medical LLCPrime Medical LLCCCX2026-03-05
00850055249325Prime Medical LLCPrime Medical LLCCCX2026-03-05
00850055249332Prime Medical LLCPrime Medical LLCCCX2026-03-05
05060624127182CS Easy Prone (170 mm) - GreyCARE SURGICAL LIMITEDCCX2026-01-26
05060624127199CS Easy Prone (170 mm) - Chest only (Grey)CARE SURGICAL LIMITEDCCX2026-01-26
05060624127342CS FlexiFin™ Stirrup Pads (Pair) – Low BMI Patients CARE SURGICAL LIMITEDCCX2026-01-26
05060624127366CS Easy Prone (150 mm) - GreyCARE SURGICAL LIMITEDCCX2026-01-26
05060624127373CS Easy Prone (150 mm) - Chest only (Grey)CARE SURGICAL LIMITEDCCX2026-01-26
05060624127397CS Easy Prone (150 mm) - Pelvis Only (Grey) CARE SURGICAL LIMITEDCCX2026-01-26
05060624127403CS Easy Prone (170 mm) - Pelvis only (Grey)CARE SURGICAL LIMITEDCCX2026-01-26
05060624127458CS Easy Prone (200 mm) - GreyCARE SURGICAL LIMITEDCCX2026-01-26
05060624127465CS Easy Prone (200 mm) - Chest only (Grey)CARE SURGICAL LIMITEDCCX2026-01-26
05060624127472CS Easy Prone (200 mm) - Pelvis only (Grey)CARE SURGICAL LIMITEDCCX2026-01-26
00199972000184CuraplexBOUND TREE MEDICAL, LLCCCX2026-01-23
00199972000191CuraplexBOUND TREE MEDICAL, LLCCCX2026-01-23
00199972000207CuraplexBOUND TREE MEDICAL, LLCCCX2026-01-23
00199972000214CuraplexBOUND TREE MEDICAL, LLCCCX2026-01-23
50749756401352DeRoyalDEROYAL INDUSTRIES, INC.CCX2026-01-22
50749756401376DeRoyalDEROYAL INDUSTRIES, INC.CCX2026-01-22