FDA.reportPublic FDA data

EXMOOR

Primary DI
05060180255022
Brand
EXMOOR
Company
EXMOOR PLASTICS LIMITED
Model
MK7NSJ1E116
Catalog number
MK7NSJ1E116
Device description
Myringotomy Kit with Grommets
Published
2019-05-30
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
JYPKnife, Myringotomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYPKnife, MyringotomyEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060180255022PackageGS110In Commercial Distribution
05060180259068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060180255022050601802550225060180255022
05060180259068050601802590685060180259068

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep out of direct sunlight.
Special Storage Condition, Specify00store in a clean, dry environment, at room temperature. Avoid extremes of temperature and humidity.
Storage Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+441823351040sales@exmoorltd.com

Regulatory Flags#

DUNS number
298725490
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
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
05060180258788EXMOOREPL/1aEPL1A2018-09-21
05060180258795EXMOOREPL/1bEPL1B2018-09-21
05060180254643EXMOOREPL1EPL1A or EPL1B2019-11-18
05060180256043EXMOORE.111E111 or E111X52018-09-10
05060180256180EXMOORE402E4022018-09-11
05060180256272EXMOORE.59E592018-09-20
05060180256319EXMOORL1L12018-09-10
05060180257798EXMOORS101S101-EX2018-09-11
05060180257866EXMOORS102S102-EX2018-09-11
05060180257873EXMOORS103S103-EX2018-09-11
05060180257880EXMOORS104S104-EX2018-09-11
05060180257934EXMOORS109S109-EX2018-09-11
05060180257972EXMOORS110S110-EX2018-09-11
05060180257989EXMOORS111S111-EX2018-09-11
05060180258139EXMOORS125S125-EX2018-09-11
05060180256258EXMOORE.58E582018-09-20
05060180256265EXMOORE.58aE58A2018-09-20
05060180256159EXMOORE.301E3012018-09-10
05060180251048EXMOORN18N182018-09-14
05060180251062EXMOORN23N232018-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD920661200Surgical DirectSurgical Direct, Inc.JYP2026-07-29
00850083275792Intrace USAPILOTIS TECH LLCJYP2026-07-03
09421901970499Adept Medical Myringotomy KnifeADEPT MEDICAL LIMITEDJYP2024-03-20
G586E7213700Novo SurgicalNOVO SURGICAL, INC.JYP2023-12-18
G586E7213780Novo SurgicalNOVO SURGICAL, INC.JYP2023-12-18
00840183515966BR Surgical, LLCBR Surgical, LLCJYP2023-04-03
00840183515973BR Surgical, LLCBR Surgical, LLCJYP2023-04-03
00842331167089Novo Surgical Inc. NOVO SURGICAL, INC.JYP2022-11-13
00842331148354Novo Surgical Inc. NOVO SURGICAL, INC.JYP2022-11-12
04046826103194MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJYP2020-09-24
04046826103200MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJYP2020-09-24
M6333814021ADEPT MEDICALJEDMED INSTRUMENT COMPANYJYP2020-09-01
M633301705HH0JEDMEDJEDMED INSTRUMENT COMPANYJYP2020-09-01
M6333814000ADEPT MEDICALJEDMED INSTRUMENT COMPANYJYP2020-09-01
M633S3814020ADEPT MEDICALJEDMED INSTRUMENT COMPANYJYP2020-09-01
04038653176366AESCULAPAesculap AGJYP2020-04-22
05060180259037EXMOOREXMOOR PLASTICS LIMITEDJYP2019-05-30
05060180259068EXMOOREXMOOR PLASTICS LIMITEDJYP2019-05-30
05060180254988EXMOOREXMOOR PLASTICS LIMITEDJYP2019-05-30
10381780082514Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYP2018-10-24
10381780084440Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYP2018-10-24
05060180252809EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180252816EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180252823EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180252830EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180252847EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180252854EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180252861EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180252878EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180252885EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11