FDA.reportPublic FDA data

ACE

Primary DI
00614950012749
Brand
ACE
Company
ACE SURGICAL SUPPLY CO., INC.
Model
0034010
Catalog number
0034010
Device description
IV ARMBOARD BLACK FOR 1040 ADEC CHAIR
Published
2019-10-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00614950012749PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00614950012749006149500127496149500127490614950012749

GMDN Terms#

Term, Definition table
TermDefinition
Armboard, reusableA device designed to stabilize a patient's arm during an intervention or procedure typically to maintain the patency of an intravenous (IV) needle or an intravascular catheter. It is typically an elongated, flat surface of expanded polystyrene, wood, or artificial fibre board that is covered with a durable plastic or coating that can be easily cleaned. It may have a metal attachment so that it can be affixed to, e.g., an operating/examination table, a blood donor couch, or a chair, or it may be placed on a flat surface (e.g., on top of an operating/examination table). This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00No special storage conditions required

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(508)588-3100ritaknight@acesurgical.com

Regulatory Flags#

DUNS number
042763706
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00614950007547OUSIA bioXENOUSM2OUSM22015-10-24
00614950007554OUSIA bioXENOUSM3OUSM32015-10-24
00614950007561OUSIA bioXENOUSM4OUSM42015-10-24
00614950007578OUSIA bioXENOUSM5OUSM52015-10-24
00614950007585OUSIA bioXENOUSM6OUSM62015-10-24
00614950007721OUSIA bioXENOUSM1OUSM12015-10-24
00614950027910Collagen Matrix509400150940012023-06-16
00614950027927Collagen Matrix509400250940022023-06-16
00614950027934MinerOss® XBH0034BH00342022-10-27
00614950027941MinerOss® XBH0035BH00352022-10-27
00614950027958MinerOss® XBH0036BH00362022-10-27
00614950027965MinerOss® XBH0037BH00372022-10-27
00614950027972MinerOss® XBH0038BH00382022-10-27
00614950027989MinerOss® XBH0039BH00392022-10-27
00614950027996MinerOss® XBH0044BH00442022-10-27
00614950028009MinerOss® XBH0045BH00452022-10-27
00614950028016MinerOss® XBH0046BH00462022-10-27
00614950028023MinerOss® XBH0047BH00472022-10-27
00614950028030MinerOss® XBH0052BH00522022-10-27
00614950028047MinerOss® XBH0053BH00532022-10-27

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00889024715295Persona Extended V/V Guide Assembly (MFS)Zimmer, Inc.LXH2026-10-19
08809986489807LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-19
00810111228671Cut GuideTreace Medical Concepts, Inc.LXH2026-10-16
00810161900305EARP, TRIAL 22X35X12 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
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00810161900329EARP, TRIAL 22X35X12 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
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