FDA.reportPublic FDA data

Smoot Ankle Distraction Strap

Primary DI
10840113230850
Brand
Smoot Ankle Distraction Strap
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
713400
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
CCXSUPPORT, PATIENT POSITION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCXSupport, Patient PositionAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840113230850PackageGS110In Commercial Distribution
00840113230853PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084011323085010840113230850
00840113230853008401132308538401132308530840113230853

GMDN Terms#

Term, Definition table
TermDefinition
Limb/torso/head restraint, single-useA non-rigid device, typically a strap(s), band(s) or garment-like, intended to be temporarily placed on or around one or more parts of a patient’s body (e.g., torso, limbs, head) to restrict movement, to facilitate patient positioning and stabilization during a medical procedure, and/or to prevent injury/hazards while potentially permitting limited movement. It is made of various materials (e.g., fabric, nylon, leather, or foam) and typically anchored to a fixture or furniture part (e.g., a bedrail, operating table). It is not intended for immobilization of specific joint. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840113233762Bovie Derm 1022026-05-11
00607151010263BovieA1250SA1250S2018-02-23
00840113244232ValleylabE15594E155942026-05-04
00840113244249ValleylabE15596E155962026-05-04
00840113244256ValleylabE15604E156042026-05-04
00840113244263ValleylabE15606E156062026-05-04
00840113244270ValleylabE15614E156142026-05-04
00840113244287ValleylabE15616E156162026-05-04
00840113244294ValleylabE15624E156242026-05-04
00840113244300ValleylabE15626E156262026-05-04
00840113244317ValleylabE15644E156442026-05-04
00840113244324ValleylabE15646E156462026-05-04
00840113244331ValleylabE16512 E16512 2026-05-04
00840113244348ValleylabE16514E165142026-05-04
00887482188873BovieA23502024-09-27
00887482188897BovieA33502024-09-27
00887482181324BovieIDS-2102024-08-26
00887482181508BovieIDS-3102024-08-26
00887482182536BovieA9422024-08-26
00887482182550BovieA9522024-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10080196413737MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-04-27
10080196413256MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-03-30
10080196413485MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-03-30
10080196413690MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-03-30
07613327632842Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCCCX2025-11-19
07613327632859SageSAGE PRODUCTS, LLCCCX2025-11-19
07613327632866SageSAGE PRODUCTS, LLCCCX2025-11-19
07613327672718Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCCCX2025-11-19
10197344149834MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-22
10197344149803MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-12
10197344149810MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-12
10197344149827MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-12
G242SB03RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SB07SDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SB12RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SS03DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SB01RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SB05SDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SB10RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS01DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS04DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS05DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS08DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS10DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS11DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS15DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
10197344161034MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-07-28
10197344158768MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-06-30
10197344100392MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-04-05
10080196413805MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-01-22