FDA.reportPublic FDA data

Dale Strapless Bendable Armboard

Primary DI
00817612021015
Brand
Dale Strapless Bendable Armboard
Company
DALE MEDICAL PRODUCTS, INC.
Model
552
Catalog number
552
Device description
Dale Strapless Bendable Armboard, Small, 4.5" x 1.75"
Published
2020-09-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
FYHSplint, Extremity, Noninflatable, External, Sterile
LCNScraper, Tongue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYHSplint, Extremity, Noninflatable, External, SterileGeneral, Plastic Surgery1
LCNScraper, TongueDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817612021015PackageGS110In Commercial Distribution
00817612021008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817612021015008176120210158176120210150817612021015
00817612021008008176120210088176120210080817612021008

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
001061233
Device count
1
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H84101501Dale Foley Catheter Holder1501502018-08-30
H84103161Dale Foley Catheter Holder3163162018-08-30
H84103301Dale Foley Catheter Holder3303302018-08-30
H84104901Dale Urodynamic Tube Holder4904902018-08-30
00817612020001Dale General Purpose Securement Device9529522018-09-10
00817612020025Dale Catheter Securement Device8538532018-09-10
00817612020124Dale Catheter Securement Device8508502018-09-10
00817612020148Dale Catheter Securement Device8518512018-09-10
00817612020162Dale Catheter Securement Device8528522018-09-10
00817612020186Dale Catheter Securement Device8548542018-09-10
00817612020209Dale General Purpose Securement Device9509502018-09-10
00817612020223Dale General Purpose Securement Device9519512018-09-10
00817612020902Dale Catheter Securement Device8498492018-09-10
00817612020926Dale Catheter Securement Device8488482018-10-10
00817612021107Dale IV Line Manager6306302025-08-11
00817612020544Dale Foley Catheter Holder1501502019-03-18
00817612020568Dale Foley Catheter Holder3163162019-03-18
00817612020582Dale Foley Catheter Holder3303302019-03-18
00817612021121Dale Airway Holder2602602026-03-11
00817612021114Dale IV Line Manager6306302025-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810131044725Adult SuperScraper SilverSupermouth LLCLCN2025-06-30
00810131044732Adult SuperScraper Rose GoldSupermouth LLCLCN2025-06-30
10304040192488Henry ScheinHENRY SCHEIN, INC.LCN2025-06-27
00304040192481Henry ScheinHENRY SCHEIN, INC.LCN2025-06-27
00810131041502Adult Resuable Tongue Scraper Supermouth LLCLCN2025-05-25
00810131041519Ortho Resuable Tongue Scraper SilverSupermouth LLCLCN2025-05-25
00810131041526Ortho Resuable Tongue Scraper Rose GoldSupermouth LLCLCN2025-05-25
00817612021008Dale Scrape-n-Suction Tongue CleanerDale Medical Products, Inc.LCN2024-12-02
00070942007849GUM® SUNSTAR AMERICAS, INC.LCN2024-10-30
D2486300621TS1 Tongue Vacuum CleanerHAGER WORLDWIDE, INC.LCN2024-08-20
D2486300620TS1 Tongue Vacuum CleanerHAGER WORLDWIDE, INC.LCN2024-08-20
00810131040529Ortho Tongue scraper SilverSupermouth LLCLCN2024-06-01
00810131040536Ortho Tongue scraper Rose GoldSupermouth LLCLCN2024-06-01
00850036799511Chocolate Kids Tongue Scraper Single ScoopSupermouth LLCLCN2024-06-01
00850036799528Strawberry Kids Tongue Scraper Single ScoopSupermouth LLCLCN2024-06-01
00850036799535Vanilla Kids Tongue Scraper Single ScoopSupermouth LLCLCN2024-06-01
00850036799542Chocolate Kids Tongue Scraper Double ScoopsSupermouth LLCLCN2024-06-01
00850036799559Strawberry Kids Tongue Scraper Double ScoopsSupermouth LLCLCN2024-06-01
00850036799566Vanilla Kids Tongue Scraper Double ScoopsSupermouth LLCLCN2024-06-01
00850036799603Adult Tongue ScraperSupermouth LLCLCN2024-06-01
00026072012208SCAllied Medical, LLCFYH2024-05-09
00026072022771SCAllied Medical, LLCFYH2024-05-09
00026072022788SCAllied Medical, LLCFYH2024-05-09
00026072022795SCAllied Medical, LLCFYH2024-05-09
00026072022801SCAllied Medical, LLCFYH2024-05-09
00026072022818SCAllied Medical, LLCFYH2024-05-09
00026072022825SCAllied Medical, LLCFYH2024-05-09
00026072022894SCAllied Medical, LLCFYH2024-05-09
00026072022900SCAllied Medical, LLCFYH2024-05-09
00817612020964Dale Post Surgical BraDale Medical Products, Inc.FYH2024-04-25